Process Web-based Seminars

Hiring Plan Webinar HIRING PLAN | Thursday, November 10, 2011 | 2: 00 PM a 5: 00 PM CST Led by Alicia Marie How do you know when it is time to hire? What role is the right one? Identify a strategy for building your organization as well as a hiring process for identifying talent. Save time, money and the headache of a bad hire. Register Here:  more...

ITIL v3 Service Offerings and Agreements Capability SOA ...ctical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Service Offerings and Agreements of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of  more...

ITIL v3 Operation Support and Analysis Capability OSA ...ctical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Operational Support and Analysis of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of  more...

ITIL v3 Planning Protection and Optimization Capability PPO ...ctical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Planning Protection and Optimization of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders  more...

ITIL v3 Release Control and Validation Capability RCV ...ctical aspects of the ITIL ® v3 Service Lifecycle and processes associated with the Release, Control and Validation of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of  more...

Inspired Goals Webinar YOU WILL LEARN: a The top three reasons why people dona ™t set goals a How to start fresh and complete past goals a The process of focus and attention a Goal setting tips a The language of goal setting a Strategy for what will likely stop you from achieving your goals a How to set goals that inspire and motivate a How to embrace failure and  more...

Webinars Online, educational sessions, describing and demonstrating key techniques and approaches to the analysis of business process and systems. Topics covered will include (in different sessions): Business Process Modelling Notation (landscapes and workflows), Unified Modelling Language (primarily use case, activity and class mdoelling), Data Modelling (entity relationship and physical schema  more...

Multivariate Data Analysis for Spectroscopy Applications Web Workshop This workshop has been designed to give participants a strong foundation in the basics and fundamentals of Multivariate Data Analysis and its applications for spectroscopy data. In this training you will learn how to pre-process your spectral data. You will also learn how you can interpret the Principal Components Analysis (PCA) and Partial Least Squares (PLS) loadings as signal.  more...

Call Center Workforce Management Certification - Live Online - August 1-3 2012 ...workforce managers covers the entire workforce management process from the gathering of data to the production of forecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just theory. When this learning is expanded to workforce management, the focus extends to  more...

Call Center Workforce Management Certification - Live Online - April 4-6 2012 ...workforce managers covers the entire workforce management process from the gathering of data to the production of forecasts, schedules, and budgets. We include lessons that benefit attendees from any sized organization, large and small, with real-world examples of solutions that work in practice - not just theory. When this learning is expanded to workforce management, the focus extends to  more...

Documentum E20-120 Training This training includes: Documentum Fundamentals Documentum Development Documentum Administration. Documentum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in  more...

Documentum 65 Training ...ntum Foundations Classes, Documentum Foundation Services, Process Builder, Forms Builder. We also give training on Documentum 6. 5 with all new and advanced topics being covered. This is done both in physical and online mode. Trainer are all EMC certified professionals and working in the field from last 7 years. For demo sessions, please visit http://www. youtube. com/ watch?  more...

LABOR RELATIONS TRAINING ... managers in dealing effectively with the labor relations process and will provide an in-depth review of your current collective bargaining agreement in terms managers can understand. We will cover concepts such as progressive discipline, effective handling of sick leave and tardiness abuse, the grievance procedure and how to ensure successful arbitrations of your grievance issues. Most  more...

HIRING DOS AND DONTS ...hat questions you can and cannot ask during the interview process. Learn how to avoid asking questions that can lead to discrimination claims later on. Also, learn what employment-at-will really means and how to avoid losing your right to hire or fire at-will. Learn how to avoid claims of implied contract that lead to breach of contract and wrongul discharge claims. This live on-line  more...

Legal Word Processing Course - Microsoft Word 2007 This comprehensive course focuses on the core formatting elements of Microsoft Word 2003, 2007 or 2010. It provides conceptual and technical learning of the software's advanced features used by international law firm staff to process complex legal documents. The KAS Training Legal Word Processing course was developed by legal trainers with more than 20 years of experience in the legal industry.  more...

TOP 10 FMLAADA MISTAKES EMPLOYERS SHOULD AVOID Learn how to avoid the pitfalls of the FMLA and ADA. Get the latest on the Amendments to the FMLA and ADA as well as the Department of Labor revisions to the FMLA Regulations. Stay Informed! This one-hour live on-line webinar provides all the information that you need to know to ensure compliance with the FMLA and ADA. Learn how to recognize a serious health condition and how to designate that  more...

QuickBooks 2009 Training This Quickbooks training class covers the fundamentals of using QuickBooks 2009 to track the finances of a small business. Students will learn how to set up a new company, work with lists, set up inventory, process invoices, work with bank accounts, process payments, enter and pay bills, and use online banking. In addition, students will learn how to customize forms, create reports and graphs,  more...

MOC 8812 - General Ledger in Microsoft Dynamics GP 10.0 In this Microsoft Dynamics GP training class, students learn to set up General Ledger, to enter and post transactions in General Ledger, to use Multidimensional Analysis, enter Intercompany transactions and set up Organizational Structures to use account security, to maintain General Ledger records, and to learn the process of closing an accounting period and the fiscal year.  more...

MOC 8819 - Payables Management I in Microsoft Dynamics GP 10.0 ...ment training class examines the accounting cycle and the processes required to enter vendor invoices and process checks. This class also shows how to perform additional functions such as adjustments, prepayments, month-end closing, and cash flow control.A thorough understanding of these topics allows for capitalizing on vendor discount dates to reduce payable liabilities and easily select the  more...

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 ...Processing class explores the accounting cycle and the processes required to enter and ship sales orders. This class shows you how to easily manage the life-cycle of your customer ' s order from the initial quote to the shipment documentation and final invoicing. You learn how to perform additional functions setting up process holds for quality assurance and linking order documents to purchase  more...

MOC 8399 - FRx 6.7 Report Design Essentials I This Microsoft FRx training class covers the basic report design skills you need to create, maintain and distribute presentation quality reports using Microsoft FRx. The class also includes coverage of additional functionality designed to help you create new reports, and distribute and analyze your company ' s financial information. You learn about basic foundational skills, complex calculations,  more...

MOC 8400 - FRx 6.7 Report Design Essentials II This advanced Microsoft FRx training class builds on the basic report design skills learned in MOC8399. Using Microsoft FRx you learn advanced report design including linking to external worksheet data, linking row formats, multi company consolidations, currency translation reporting and cash flow. A combination of instructor guided exercises and practice tutorials allow students to master their  more...

MOC 8671 - Bank Reconciliation I in Microsoft Dynamics GP 10.0 ...tion training class explores the accounting cycle and the processes required to manage cash receipts, cash disbursements, and other transactions that affect checkbook balances. This class shows you how to perform the reconciliation process, ensuring accuracy of your financial data and its relation to your financial institution.A thorough understanding of these topics allows you to reconcile  more...

MOC 8811 - Foundation I in Microsoft Dynamics GP 10.0 This Microsoft Dynamics GP Foundation training class explores the basic elements of Microsoft Dynamics GP. Topics covered during this session include: system and company setup procedures, how to use reports and inquiries, how to use SmartList to expand inquiry and analysis capabilities, business alerts, process server and tips for the user to personalize shortcuts and checklists to streamline  more...

MOC 3938 - Updating Your Skills from Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 to Microsoft Exchange Serv This Microsoft Exchange training class targets Microsoft Exchange 2000 Server or Microsoft Exchange Server 2003 administrators who need to upgrade their skills to manage a Microsoft Exchange Server 2007 infrastructure. This class focuses on the new features and administrative tasks in Exchange Server 2007.Students will learn skills that enable them to deploy and manage an Exchange Server 2007  more...

Business Ethics Training ...business ethics. Students learn about the decision-making process to solve ethical dilemmas, understanding barriers and consequences when making ethical decisions, and the process for blowing the whistle when unethical situations arise. Course activities also cover identifying common managerial ethical issues, being proactive with ethical issues, addressing subordinates ' ethical issues,  more...

Introduction to ColdFusion Training This is an introductory ColdFusion class for Web designers who are brand new to ColdFusion. You will learn to process forms, manage sessions, write reusable code and create database-driven ColdFusion-based websites.  more...

Change Management Training This change management training course teaches students how to develop the skills to proactively address change and meet the challenges of transition in the workplace. Students will work with various employees to overcome the problems encountered when making changes in your organization. Students will also learn how to develop the ability to effectively handle organizational changes by examining  more...

Business Problem Solving and Strategic Decision Making ...oblem solving, and identify phases of the problem-solving process. The course also covers the process for generating solutions and a method for prioritizing problems, the ability to identify a problem ' s root causes, develop and implement an effective solution, track the success of your solution, and define multiple analysis techniques and different methods to reach conclusions. Students also  more...

Introduction to Active Server Pages ... to remember users with cookies and sessions, collect and process information users enter into an online form, and provide rich integration with databases to track clients, orders, and products using ASP and the enhanced functionality of ASP components. Students will also learn to use sophisticated programming strategies and advanced features to add polish, speed and efficiency to Active  more...

Managing Performance Training This Managing Performance training course teaches students the basics of creating a performance plan and the appraisal process. Students will learn how to conduct a performance-planning meeting, document the performance plan, provide positive and constructive feedback, coach employees during the appraisal period, appraise employee  more...

Project Management Training ...roject, the steps and variables of the project management process, the effects of environmental, socioeconomic and organizational structure issues, and the responsibilities of a project manager. Course activities also cover defining the project scope, writing a project charter, developing a work breakdown structure, identifying time management components, describing schedule development, using  more...

Motivation Training In this motivation training course students will discuss the foundations of motivation. They will examine motivating and demotivating factors as well as negative thoughts. They will also discuss motivation theories and the benefits of motivation. Students will examine the concept of having a Positive Mental Attitude, and how they can work towards a PMA in their lives. During this course, students  more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs ...which in turn drives the Master Production Schedule (MPS) process. Start with an inaccurate shipment forecast and a poor performing MPS is sure to follow. Continue with a poor forecasting process and inventory will surely balloon at the same time customer shortages increase. When forecasting is an afterthought, no one is happy! To be presented on January 19, 2012. This montha ™s  more...

Understanding Improving Yields Scrap Rework ...ements that tell us different things about our production processes. Measuring and monitoring them precisely (and individually) is an important component of any process improvement initiative. If these values get comingled in the measurement procedures, underlying root cause analysis is certain to result. This FREE 1-hour webinar presents the CORRECT definitions of yield, scrap and rework.  more...

JIRA Workflow Administration Webinar The JIRA Workflow Administration training course covers all administrative features of JIRA related to customisation of the workflow and data capture. Attendees from this session will become proficient with creation of custom fields, new issue types, workflow statuses, transitions, post functions, field configurations, mandatory fields, hidden fields, workflow schemes and applying a JIRA workflow  more...

Better Methods for Maintaining Accurate Operation Standards ...tone of successful capacity planning, work order control, process flow planning and cost accounting. There are few data elements in a manufacturing company's database that require the attention that operation standards require. This LIVE and INTERACTIVE 90-minute workshop will present several ideas for better maintenance of these standards. The instructor will share methods that he has  more...

Constructing a Component Criticality Matrix A Better Way to Identify Important Components Procurement organizations are often responsible for managing thousands of parts that can be purchased from hundreds of Suppliers. The large number of parts and Suppliers makes it nearly impossible to manage each individual part as much as one wants to. This is why Procurement organizations rely upon stratification methods and other sorting methodologies to provide insights into GROUPS of parts.  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...he condition of the data necessary to the decision making process itself. No longer is a manager responsible solely for reporting economic results and departmental performance. Today's manager must measure, monitor and report the condition of data utilized in the decision making process much the same way pollsters and scientists measure the quality of data going into their political polls and  more...

Integrative Activity Based Costing Leadership An Overview of Bottom Up Cost Accounting ... to eliminate all non-value adding activities and begin a process reengineering journey. - A willingness to implement a culture of waste hounds throughout the organization. ABCA is a managerial cost accounting system which determines the cost of activities without distortion and provides management with relevant and timely information. ABCA represents a new way to look at operating  more...

A Case for Routine Use of Statistical Process Control SPC in Manufacturing ...mprovement webinar, A Case for Routine Use of Statistical Process Control (SPC) in Manufacturing. Statistical Process Control is a term that describes a process for predicting failures and methodically determining the underlying cause(s) before the predicted failures can manifest into real failures. SPC represents a progressive set of predicted and predictive technical tools that any  more...

A Better Method for Cross Training Production Personnel ... will present several ideas for building a cross-training process in your manufacturing organization. Specifically, this webinar will address: a How to construct a cross-training program in operations building a successful program with little or no involvement from HR. a How to identify the Job Masters and then get them to share their experiences and skills with  more...

Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel ...processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates to process capability. The presentation illustrates  more...

Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated - Webinar By GlobalCompli This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. The FiM and other Phase I studies set the tone of all future Pre NDA studies. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...k at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Areas Covered In the Session: The new regulations will be reviewed and their effects on usual practices will be discussed, as well as what policies need to be changed and how. We will show what policies and evidence you need to produce if you are  more...

Supply Chain Risk Management - Webinar By GlobalCompliancePanel Overview: For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. Non Financial firms are now increasing their risk management especially in the light of such complex, global, and out sourced supply chains. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and  more...

Drug Development Process - From Discovery to Marketing - Webinar By GlobalCompliancePanel This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. Wednesday, February 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Lyophilization Process Development and Cycle Design with a Case Study - Webinar By GlobalCompliancePanel This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. Wednesday, January 11, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Risk Assessment - Compliance Using Easy To Fill Out Documentation - Webinar By GlobalCompliancePanel This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. Tuesday, February 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Key Steps for Risk Assessment - Webinar By GlobalCompliancePanel ...ementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby  more...

Statistics in Quality Control - Critical decisions-Risks Basics - Webinar By GlobalCompliancePanel Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Why is Drug Induced Liver Injury an Important Mirror of Drug Safety and How to Spot this early - Webinar By mentorhealth Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1: 10, 000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. Wednesday, November 30, 2011 10: 00 AM PST | 01:  more...

New Process Validation Life-Cycle Approach - Apply statistical tools to demonstrate Process Capability - Webinar By GlobalCompli This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Troubleshooting Ethylene Oxide EO Processes - Webinar By GlobalCompliancePanel Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Bullet Proof 510k - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Thursday, November 17, 2011 10: 00 AM PST | 01: 00 PM EST  more...

New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel ...ill clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the study team and site staff participating in the clinical trial plays an important key role. Knowledge of ethics regulations will  more...

Best Practices in Complaint Management - Webinar By GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. Wednesday, November 2, 2011 10: 00  more...

Advanced HR Audit Techniques - Webinar By TrainHR ...the status and evolution of HR audits. The HR auditing process is or should be an independent, objective, and systematic evaluation that provides assurance that: 1) compliance and governance requirements are being met 2) business and talent management objectives are being achieved 3) human resource management risks are fully identified, assessed, and managed; and 4) the organizationa  more...

Designing and Conducting Effective Structured Interviews - Webinar By TrainHR This webinar will cover the process of determining the right questions to predict success on the job, including questions to determine a cultural match to the organization, how to design a program with the advantages of structured interviews and elimination of the disadvantages some programs have  more...

Documenting Performance and Administrating Progressive Discipline - Webinar By TrainHR ... cover discipline policies, standards of conduct, and the process of documenting performance and administrating progressive discipline, up to and including termination. It will also cover the objectives of discipline, the reasons for substandard performance, investigating circumstances and documenting discipline, the difference between counseling and coaching, when you can bypass the step by  more...

Job Evaluation Methods and Plans - Webinar By TrainHR Overview : In this program the speaker will review the purpose and types of Job Evaluation Plans, used to establish grade levels for a company's job classifications. Job Evaluation Plans such as Ranking, Paired Comparison, Whole Job Method, Hay Plan, Factor Comparison, GS Classification System, Single Factor, Limited Factor, and Competency based plans will be addressed. In addition, the factors  more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the  more...

Calculating Overtime Correctly - Webinar By TrainHR ... calculating overtime and common pitfalls involved in the process. The importance of being thorough and correct when calculating regular rate of pay to avoid massive Department of Labor penalties is also highlighted as well as its importance in avoidance of suffering damages from civil law suits. Why you should attend: Calculating overtime is simple, right? Ita ™s just time and a  more...

Proper and Effective Handling of Child Support Garnishments - Webinar By TrainHR The information provided in this program will help the attendee accurately and completely process Child Support garnishment orders through the payroll department in compliance with federal and state requirements and regulations  more...

ITIL v3 Service Operation Virtual Instructor Led ...in ITIL ® v3 from the point of view of the owner of a process or set of activities. The course is intended for those who work within a Service Operation (SO) environment and require a deeper understanding of the underlying concepts, processes/ functions and activities involved and management responsibilities and how they may be used to enhance overall service quality and service provision.  more...

The FDA Inspection Process From SOP to 483 - Webinar By GlobalCompliancePanel This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

Designing an Effective Cleaning Validation in todays Regulatory Environment - Webinar By GlobalCompliancePanel This webinar concentrates on designing effective cleaning validation studies. Key benefits of this seminar include: Learn what steps should be followed. Identify critical parts of cleaning validation process. Achieve satisfactory inspections. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls.  more...

The 510k Process Risk Management - By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

The 510k Process Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

The 510k Process and Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

Statistical Applications - Webinar By GlobalCompliancePanel Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more.  more...

SAP FICO Online Competency Development Training program ...but gives you a good idea about our training to placement process) During the Training: Video 1 a Explains what our training program consists of Video 2 - Overview Video of the course (Explained by the Trainer)-> Video 3 - What Happens after you Signup ? Video 4 a During the training process - Video 5 - Instructor-led Online Training Benefits a Click here Video 6 a List of  more...

JAVA J2EE JEE Professional Role Based Training from Zaran Tech ...but gives you a good idea about our training to placement process) During the Training: Video 1 a Explains what our training program consists of Video 2 a What happens after you Signup? - Video 3 - During the Training Process - Video 4 a How we use Googledocs to share documents/ materials - Video 5 - Instructor-led Online Training Benefits a Click here After the Training  more...

SAP BOBJ with BW integration Online Competency Development Training program ...but gives you a good idea about our training to placement process) During the Training: Video 1 - SAP BOBJ Training program Explained, Video 2 - What Happens after you Signup ? Video 3 a During the training process - Video 4 - Instructor-led Online Training Benefits a Click here Video 5 - Demo Video Recording (From the Trainer) - After the Training Process: Video a After the  more...

Business Analyst Competency Development Program ...ng and Capturing business needs 3. Requirement Analysis Process 4. Creating Requirement gathering strategy 5. Modeling Data and Processes 6. UML Methodology 7. Creating Effective Use Cases 8. Business Analysis Tools 9. Requirement Gathering, Business Modeling & Analysis Tools - MS Visio & Enterprise Architect 10. Project Documentation and Management 11. Software Testing 12.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...t them into an effective 21 CFR Part 11 CGMP software V&V process. Why you should attend: Software has become pervasive in medical product manufacturing documentation and cGMP compliance actions, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being  more...

Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies.  more...

Residual Risk and Risk based Verification Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach.  more...

Verification vs Validation in Regulated Industries - webinars by gcp Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...n via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness. Why should you attend: Radiation sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the  more...

Statistical Concepts of Process Validation BY GCP The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".  more...

Lyophilization What you Need to Know Validation and Regulatory Approaches by gcp This course explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.  more...

Risk Assessment - Compliance Using Easy To Fill Out Documentation BY GCP This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance  more...

CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  more...

Creation and configuration of a Equipment Facilities and Preventive Maintenance System utilizing the principles of Lean Document Proper preventive maintenance and management of process equipment, and facilities is the foundation for any manufacturing process, including many processes not typically thought of as manufacturing.  more...

Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin ...prove the quality, reliability and safety of products and processes in a proactive manner. It has been used successfully for over 60 years in very type of industry and in all stages of product development, process improvement projects. It helps to increase customer satisfaction, by proactively addressing failures that keep us from meeting critical customer requirements in processes or  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel ...health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common  more...

Master Production Record Requirements - Webinar By GlobalCompliancePanel ...esign of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by "list of components", the session will cover attachments and documentation expectations. Finally, the webinar will review the process and requirements for issuance and handling of  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel ...ed for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or  more...

Introduction to Risk Management - Webinar by GlobalCompliancePanel This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk  more...

Product Recalls - Planning and Conducting Food Recall - Webinar By GlobalCompliancePanel Creating an effective Product recall process that will protect both the consumer and company's/ brand's reputation requires careful planning and active involvement of each involved department.  more...

Webinar on Specification Development - By GlobalCompliancePanel A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract.  more...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/ preventive actions to prevent the repetition of these occurrences in the future. Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...s session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. We will discuss what information and documentation needs to  more...

Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...d taking regular actions as part of a security management process. Proposed changes and expansions to HIPAA, going into effect in 2011, dramatically expand the types of entities to which the regulations directly apply, which means that more entities than ever need to adopt the proper HIPAA Security policies and procedures to be in compliance. HHS compliance audit activity and enforcement  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...ance and assisting in the information security management process. Having good policies provide the foundation of good practices and compliance - we will discuss a set of topics that should be covered in a good set of information security policies meeting HIPAA and PCI requirements. Areas Covered in the Session: * Health and payment information must be kept securely - learn what is  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ... it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security Risk Analysis Process presented utilizes a non-technical approach, involving interviewing staff knowledgeable about operations and systems to discover how  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...al Practice will ensure quality data, speed up the review process, and decreases the costs to sponsors. This Webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines. Why Should You Attend: All CROa ™s, Sites, and Sponsors of Clinical Research involved in the drug and  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application to all medical products. They will  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...he nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP  more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel Overview: CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM. The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical,  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...rements and implement them into an effective software V&V process. Why Should You Attend: Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for medical imaging, and even though  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel Overview: Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...les of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You  more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel Overview: This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints. FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture. FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. Why Should You Attend: More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ... and systems. This presentation will describe a proven process for preparing a site for inspection of systems. Case studies will be used to illustrate how this process has successfully prepared several pharmaceutical companies to answer this question accurately, completely and to the great satisfaction of the inspectors. We will review and illustrate audit plans, system inventory, system  more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel Overview: This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The webinar is also designed to help differentiate Work Instructions from Standard operating procedures. Attendees will learn the steps used to write effective work instructions and Standard operating procedures. Why Should You Attend: The current shift in FDA  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ... incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Areas Covered in the  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...hy risk-based approaches are vital to the decision-making process * How to improve and bullet-proof your product complaint management system with investigations Who will benefit: This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. The employees who will benefit include: *  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel Overview: Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Data Security Analysis for Healthcare Providers: The "meaningful use" rules relating to the adoption of Electronic Medical Records require regular assessment of data security risks. HIPAA re-contains similar requirements. However, many healthcare providers fail to take the necessary steps to analyze their security risks or assess their vulnerabilities. This presentation would address  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel Overview: The Cloud Computing / Software as a Service (SaaS) Webinar will present the best practices for the validation of a SaaS Customer Relationship Management (CRM) Solution. Our presentation will offer an introduction to cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...rse provides a complete description of Z1. 4, showing the process from receiving the lot to selecting the sample size to making the accept/ reject decision. We will discuss the following issues: * How to use the sampling tables to determine the sampling plan * Ways to avoid common errors and misunderstandings with the sampling tables * The difference between single, double, and  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...esign of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by "list of components", the session will cover attachments and documentation expectations. Finally, the webinar will review the process and requirements for issuance and handling of  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel Overview: As anyone that has been involved in a traditional paper-based validation project can attest to the ability to manage the validation deliverables, timelines, resources, tasks and the compliance of the project can be difficult, resource extensive and time consuming. Most paper-based validation practices require many documents that are managed both electronically (in multiple systems)  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables. Key benefits of this seminar include: * In-dept understanding of cleanroom garments and their use. * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily.  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...oom cleaning Why should you attend: Cleanroom cleaning processes and methods have been scrutinized by FDA auditors due to their important role in cleanroom management. Poor or substandard cleaning can result in manufacturing delays, nonconformances, recalls, and regulatory action. Therefore it is important to control cleanroom cleaning processes and ensure best practices are followed.  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel Overview: Laboratory equipment should be calibrated and/ or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ...sis) but a FMEA conducted late in the product development process is largely a documentation exercise - rarely does this FMEA affect the design. Emphasis is placed on enhancing the power and benefits of FMEA for your organization by avoiding common pitfalls and concentrating efforts toward the real value of the FMEA process. Areas Covered in the Session: * What is an FMEA o  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ... a Pharmaceutical Quality System through the inspectional process. It is clear that pharmaceutical companies should be proactively considering the implementation of a Pharmaceutical Quality System. Most people are still trying to figure out what a Pharmaceutical Quality System is. Many of the components of a Pharmaceutical Quality System are in place in most companies. The various FDA and ICH  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...ming Controls * Module 12 - Comparing the Control of Processes * Module 12 - Packaging and Labeling Comparisons * Module 13 - Laboratory Controls and Device Evaluation * Module 14 - Holding, Distribution, & Returns * Module 15 - Problem Solving-Deviations, Complaints, and CAPA * Module 16 - How about Part 11 * Module 18 - Current Trends * Module 17 -  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...turing, or validation lots. Why should you attend: The process for the disposition of product lots can be tedious and overwhelming. The requirements for intermediates, Active Pharmaceutical Ingredients (API), drug substances, medical devices, finished product, and even in-house manufactured components must meet certain specifications and/ or regulatory requirements to ensure the identity,  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel Overview: This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...nt international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory requirements, and it will have recommendations and provide tools for effective  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel Overview: HIPAA Business Associate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: * The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. * The suggested and  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...hes o Using an Information Security Management Process o Using Risk Analysis and Risk Assessment o The HIPAA Security Safeguards o Information Security, Incident, and Breach Notification Policies o The Importance of Documentation * Enforcement and Audits o New HIPAA Violation Categories and Penalties o Preparing  more...

Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina Overview: The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel Overview: The webinar examines critical parts of design control after product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your  more...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel Overview: Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recalls, FDA Warning letters & even seizures could result. This presentation will review the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included.  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel Overview: This presentation discusses practical methods of performing Overall Residual Risk Evaluation and methods for documenting the results of the evaluation activity. Overall Residual Risk Evaluation requires a cross-functional team to perform the evaluation, which will be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel ... reviews and testing, the product should move through the process quickly and efficiently. We will especially look at the risk management documentation requirements and how to provide the information requested. Why you should attend: In 2012, IEC 60601-1 3rd Edition will be the requirement for product certification in Europe and Canada. In 2012, the US will join these countries in full  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel Overview: This presentation will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements. Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product,  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...uidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics process validation up to par with the advanced and modern  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs). Because many RMM technologies consist of a  more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...tions. Topics will examine each step of the investigation process from failure identification and notification through documentation. Participants will review root cause analysis techniques and observe how to identify corrective and/ or preventive actions towards successful remediation and closeout. This high-level overview will provide clarification on the steps of an effective investigation,  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...ation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the recruiting process is a  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel Overview: This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel Overview: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...en a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...tory/ quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of this course is to provide an  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...see is to arrange your internal audit scheme to mimic the process the FDA inspector will use. If you perform your internal audits this way, you'll be well prepared for the FDA. Areas Covered In the Seminar: * History of FDA inspection methodologies, from haphazard to QSIT. * Anticipate and prepare for FDA inspection. * Identify what inspectors look for during a QSIT  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel Overview: Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...ive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as preparation of the response to  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel Overview: This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel Overview: Medical devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ... Identify and decide on study management technologies and processes i. e. specific project management software to be used in the study, is the study going to use electric data capture. Areas Covered in the Session: * What is a Project and why is it important for running clinical trials? o Defining the key characteristics of project management and the importance to clinical  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ... for Pharma * Product Hazard Analysis * Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis * Fault Tree Analysis * Suggested Risk Management File / Report, FMECA, FTA Templates * The Team and Its Involvement - Who, When and How * Using the Completed Document - It's Real Value "In the Loop" Who Will Benefit: * Senior management in  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and  more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel ...onship Between Utility and Risk Aversion * Apply the Processes and Tools of Portfolio Management * Appreciate the limitations of Alpha, Beta, and related tools * Avoid the Landmines of Portfolio Management PART THREE * Differentiate the Major Types of Credit Risk * Calculate Expected Losses * Grasp the Pivotal Role Basel II and Basel III Plays in Global  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...xcel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results you want. We explain the built in Validation tools and how to use them to prevent  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...re: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals * Minimize nonconformances * Reduce rates of batch rework and rejections * Avoid product recalls Why you should attend: Regulatory agencies expect  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a daunting task  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...the technical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can be impacted by varying interpretations of the regulation if not properly addressed. This session will provide a focus on understanding the key  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ...n the midst of the changeover and the U. S. has begun the process. Are you ready for these changes? Why should you attend: If you are an accounting professional you need to become familiar with exactly what these new International Financial Reporting Standards consist of, and what these changes mean for companies. Areas Covered in the Session: * GAAP vs. IFRS * What will  more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel Overview: This presentation will attempt to remove the fear of statistics that most people share. We will not spend much time on complex equations. Rather, we will focus on the concepts of statistics, and how you can use these concepts to interpret your laboratory results. Our focus will be on using basic spreadsheet functions to compare data sets generated from many different kinds of test  more...

SAP Profitability Analysis COPA SAP Expert Training on Controlling and Profitability Analysis Modules ERP -- SAP Area -- Finance Specialization -- Controlling and Costing Course -- CO-PA Number of Hours -- 30 Hours Please contact for Demo Class sriman@ficoanalyst. com Expert Advice, Blueprint Discussion, Configuration, Process Executuion, Hands on Training, Testing Templates, Cutover  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...elps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel ...tention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices. Why  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority. By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable  more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...nning and Realization of Safe Products a flow diagrams, process steps and control measures * Hazard Assessment - Control Measures * Design and Redesign of HACCP Plan a Critical control points * Verification * Corrections and Corrective Actions * Handling of Potentially Unsafe Products * Recalls * Verification, Validation and Improvement of Food Safety  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel Overview: The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize  more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement  more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: This webinar points out current labeling issues including misbranding that are eating into profitability of dietary companies. The webinar teaches the attendee how to avoid common labeling compliance issues including: * Misbranding * Misleading claims * Misleading statements * Directions of use The webinar focuses on general labeling provisions for dietary  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...(the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...fice applications software, such as spreadsheets and word processing? * How can this be addressed? * What does "science-based" mean? * What are current 483 and Warning Letters indicating, and what can we learn from these? * What benefits beside regulatory compliance can be achieved for a company? Areas Covered in the Session: * Tougher FDA and EU MDD Software V&V  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...ring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan". Areas Covered in the Session: * Why formal Project Management * The three most common tools * How to compile * Gantt, CPM, PERT * Simple construction techniques * Work breakdown Structure,  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...cause some in industry to think that training is a simple process. However, for training to be an effective and efficient tool that contributes to performance, it must be done properly. Areas Covered in the Session: * Review of GMP regulatory expectations of training (FDA and EU) * Recent training-related citations * High-Level description of a training system, including  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ... accounts and business. Many organizations are new to the process of audits and associated standards. Thus, they are seeking out expensive consultations and/ or are requesting pre-assessments to prepare for audits. In order to work cost effectively, allocating resources and dollars to professional help with developing better systems rather than simply reviewing current programs, the supplier  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...ion of the quality system and should be a well-controlled process. FDA feels CAPA is a very important process so it is always inspected as a part of routine inspections, and it usually one of the first quality management subsystems to be reviewed by investigators. Areas Covered in the Session: * Review CAPA citations in FDA-483 and Warning Letters * Identify common problems with  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...ation of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. The investigation system will be integrated with the CAPA and Change Control Systems. Why you should attend: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA - mainly  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...th information. While many entities have gone through the processes necessary for HIPAA Security Rule compliance, many are only partially in compliance and have not performed all the steps necessary for compliance. Many may be doing many of the right things for compliance, but have not documented their policies and procedures and compliance activities as required. And many may be exposing  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes,  more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel Overview: All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel Overview: This presentation will review the Medical Device Reporting regulations and common violations leading to Warning Letter filings by FDA. As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel Overview: While not captured in most audit reports, one of the biggest mistakes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ... and what types of risks are involved throughout any food process, assigning quantitative values to those risks, measuring the processes based on risk factors and ranking risk areas for purposes of preventive and corrective actions. Risk management requires no more or less management skill levels than any production, quality or purchasing operation - risk management simply requires attention.  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...e the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...ar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA:  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ... incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? Areas Covered in the  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...k at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. In addition, there are new kinds of businesses that are considered to be business associates, such as  more...

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel Overview: Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ...on approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process  more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel Overview: A how to guide to meeting customer expectations of the maintenance function. An overview of industry best practices and a review of some leading software solutions. Why you should attend: Maintenance is often found to present the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane Overview: This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result  more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel Overview: The purpose of auditing is to identify failures in the system or gross negligence. The real question, "how bad does the system need to be for auditing to work?" This talk will look at statistical distribution for rare events to show that the sample size needs to larger when the systems are better. This is a paradox for most auditors who when a problem is discovered increase their  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel Overview: In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. Examination of two recently published reports by the FDA's CDRH (devices) have identified major areas of concerns: 1) 510(k) Working Group's Preliminary Report and Recommendations, and 2)  more...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel ...: The structure of ISO 9001: 2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: * Management of  more...

The Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel Overview: It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT  more...

Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel Overview: With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested. As a matter of fact, the Audit Committee has the PRIMARY responsibility for oversight of internal controls. One thing audit committee member should expect is to have a clear understanding of  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel Overview: The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar.  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...rganizations as Toyota's quality failures, banking's loan processing failures, organizations need to address operational risk in a holistic and systematic process. This course will provide an overview of the Basel framework to operational risk and argue that is a viable means for non-banking organizations to categorize and classify the major areas of operational risk. We will do a deeper dive  more...

Know Your Customer - The DEA Due Diligence - Webinar By GlobalComplaincePanel This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans - Webinar by GlobalCompliancePanel This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plana ™s performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success, and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel ...process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate  more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel Training is required in a number of areas of the HIPAA regulations and their policy implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to  more...

Process Verification and Validation - by GlobalCompliancePanel ...ent, implementation, or refinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use of existing FDA tools by a company will be discussed. What are the  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel ...e the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for pharmaceuticals and Part 820 for medical devices as well as pertinent passages of the International  more...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel Excel Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for  more...

Complaint Handling in Compliance with FDA and ISO Regulations - Webinar by GlobalCompliancePanel This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also  more...

Root Cause Analysis Shutting Down the Alligator Farm - Webinar by GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural  more...