Should Web-based Seminars

Spiritual Practice Path Bob Dylan has a song lyric that says 'You gonna have to serve somebody'; as in practice some form of spiritual worship. That may or may not be true, but it's definitely true that anyone interested in personal growth and development has to take the chance now and then to stop and examine their beliefs and practices. We're not going to discard anything here, over 4 weeks (with a 2 month check in)  more...

LABOR RELATIONS TRAINING ...mportantly, we will teach your managers that they can and should still effectively manage their employees despite the limitations placed on them by the union contract. All this and more in this interesting a how toa course on effectively managing all of your employees in a represented environment. This course can be customized to include your actual collective bargaining agreement and an  more...

Top Tips To Prevent Workplace Violence in your Workplace ... what the employer's workplace violence prevention policy should include and instructs employees on the proper methods to file a complaint of workplace violence. Date: November 15, 2010 Time: 1: 00-2: 00 p. m. EST Cost:$199 per attendee per computer terminal Registration: Register On-Line Now. Add to your shopping cart. You may also contact us at 917-417-1715 or via e-mail at  more...

Employee Handbooks Dos and Donts ...r employee handbook as well as phrases and terms that you should never use in such a handbook. This informative seminar will outline for you the dos and dona ™ts of drafting an effective well-written employee handbook. It will examine what the courts have said on these issues and provide practical tips on avoiding liability in the future. Learning Objectives a How to  more...

Top Tips For Managers to Prevent Harassment in your Workplace ...t in Your Workplace," will provide the tips that managers should not be without. It includes a definition of sexual harassment and discussions of quid pro quo and hostile work environment sexual harassment. The webinar provides examples from actual court cases. It focuses on an employer's obligations when there has been an incident of sexual harassment as well as strategies on how best to  more...

TOP 10 TIPS FOR CREATING A BLOGGING AND SOCIAL MEDIA POLICY ...al Media Policy a Doa ™s and Dona ™ts For What Should Be Included in the Policy a Blogger Beware! The Dangers of Failing to Draft Such a Policy a Tips For Managing the Risks of Social Media Technology a Revising Other Policies to Cover Social Media Issues a Training your Employees on your Social Media Policy Date: October 20, 2010 Time: 1:  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...

Advanced QuarkXPress 7 Training ...layouts.As you begin this QuarkXPress training class, you should already have a basic understanding of how QuarkXPress works. You may be able to create simple layouts and perform basic tasks, but find that is not enough to effectively work within a more professional, fast-paced environment. You need to build on your existing skills to learn some of the more advanced features of QuarkXPress, as  more...

MOC 5047 - Introduction to Installing and Managing Microsoft Exchange Server 2007 SP1 In this Microsoft Exchange training class, students who are new to Microsoft Exchange Server will learn how to configure and manage a messaging environment in accordance with technical requirements. Students will learn how to install Microsoft Exchange Server 2007 and manage routing, client access, and the backup and restore of databases. They will also learn how to manage addressing and recipient  more...

MOC 5928 - Managing Projects This Microsoft Project training class provides students with the knowledge and skills to initiate, plan, execute, monitor and control, and close enterprise projects by using the Microsoft Office Project Server 2007 enterprise tool.This is the second class in the Microsoft Office Project 2007 Official Curriculum series and covers the Microsoft Enterprise Project Management (EPM) Solution.This  more...

MOC 5060 - Implementing Windows SharePoint Services 3.0 ...in their organizations.The class emphasizes that students should think about the architecture of their entire environment, including business and application needs, during the planning and deployment phases. The course covers how to perform a clean installation of WSS 3.0 and also describes all the prerequisites required to select the most appropriate method for upgrading WSS from 2.0 to 3.0 in  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing ...d gross assets and improved enterprise valuation. - How should procurement function metrics be aligned with other metrics in a global sourcing manufacturing company and how do you get your critical Suppliers to align their performance metrics with yours? Participants in this montha ™s important one-hour webinar are sure to receive ideas, that when implemented, will lead to a more  more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs ...rket Requirements Definitiona (MRD) document and how it should be created and maintained. 4. Learn how to better use past shipment data to more closely predict future shipments. 5. Learn the importance of acquiring current (or real-time), data in order to make appropriate short-term forecast adjustments. Participants in this montha ™s important one-hour 3rd Thursday - a  more...

Understanding Improving Yields Scrap Rework Scrap and yield are different measurements 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  more...

The Most Important Metrics For Measuring Supply Chain Performance The Manufacturing Executive Institute is pleased to bring you this LIVE & FULLY interactive 90-minute a Modem Chat Seriesa Webinar - "The Most Important Metrics for Measuring Supply Chain Performance." This webinar is fully interactive, with instructors, moderator and all participants interacting over the webinara ™s audio channel. Operations and logistics organizations utilize a  more...

How to Factually Evaluate Critical Supplier Performance and Risks ...s? If you answered YES to any of these questions, you should attend this FREE webinar. Alan G. Dunn, President of GDI Consulting & Training Company will share how GDI's Supplier Assessment Practice performs Comprehensive Supplier Performance & Risk Assessments at supplier sites across the globe. These assessments are fact-based evaluations of suppliers that result in a clinical evaluation  more...

Better Methods for Maintaining Accurate Operation Standards ...lly interactive LIVE web conference format. Participants should be prepared to openly discuss their ideas and to interactively comment on other participanta ™s ideas presented during this LIVE webinar. This program should be attended by anyone who is responsible for, or depends upon, accurate operation standards. The program should be particularly beneficial to anyone who is  more...

Should Under-Utilized Capacity Costs Be Included in Work Center Burden Rates ...FULLY interactive 90-minute "Virtual Classroom" webinar," Should Under-Utilized Capacity Be Included in Work Center Burden Rates?" When your factory is underutilized, your productsa ™ incremental fixed cost is increased. As your factory gets more utilized, the allocated incremental fixed-costs decrease, thus increasing your companya ™s gross margins. But what happens to product  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar GlobalCompliancePanel 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. Tuesday, January 10, 2012 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...

How to Prepare for Manage and Follow-up to an FDA Inspection - Webinar By GlobalCompliancePanel The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!  more...

Advanced HR Audit Techniques - Webinar By TrainHR ... 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 ™s human  more...

Calculating Overtime Correctly - Webinar By TrainHR ...nce of suffering damages from civil law suits. Why you should attend: Calculating overtime is simple, right? Ita ™s just time and a half! What is so tough about that? Not so fast. Overtime is based on the regular rate of pay, and calculating the regular rate of pay is more complex than it appears. Whata ™s included in the calculation? The reasonable cost of meals, lodging,  more...

Corporate Integrity Agreements Offer A Second Chance - Webinar By mentorhealth Health Care Providers that find unintentional coding or documentation errors and report them to their Medicare Contractors or Intermediaries or private payers should not worry about being subject to CIA's. Thursday, October 27, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...should attend: Manufacturers of human medical products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal fashion. Thus, each element in a manufacturer's control program  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...

Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted.  more...

SAP FICO Online Competency Development Training program ...d Tips 2. Mock Interviews and Interview Preparation Tips should Here are some videos explaining how we conduct our training program, use Training Blogs and Google documents to communicate with our trainees and share the Assignments, Video Recordings, Training documents, Training materials for our training program, (each video is less than 5 min long but gives you a good idea about our  more...

JAVA J2EE JEE Professional Role Based Training from Zaran Tech ...d Tips 2. Mock Interviews and Interview Preparation Tips should attend? Following professionals should plan on joining: a Entry-level IT a Non IT professionals aspiring to get into J2EE/ JEE. a Self-taught IT J2EE/ JEE wanting to fill in the gaps and put all the pieces together a Systems Analysts and programmers interested in expanding their role into new Technology. Here  more...

Business Analyst Competency Development Program ...sts, manage risk & regulation and leverage talent. Who should attend? a Entry-level IT Business Analysts a Non IT professionals aspiring to get into Business analysis/ analyst. a Self-taught IT Business Analysts wanting to fill in the gaps and put all the pieces together a Systems Analysts and programmers interested in expanding their role into the business area. About the  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...tive 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 developed for routing,  more...

Practical Laboratory Statistics ...rated from many different kinds of test equipment. Why Should You Attend: Most people hate statistics, because they don't understand statistics. If you either generate or review laboratory data, you will want to attend this seminar. We will discuss the basics in a way that doesn't involve lots of jargon and complicated equations. We use real world examples and common spreadsheet functions to  more...

FDA Inspections - Dos Donts - webinars by gcp The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

Design Planning and Conducting Effective Audits - Webinars by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement.  more...

FDA Inspections - Dos Donts The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

Design Planning and Conducting Effective Audits by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...equirements 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 related standards is crucial to proper compliance. In addition, understanding the requirements and integrating them  more...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare by GCP 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...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...gy looking backwards, which is counter productive. Why should you attend: Most employees hate appraisals and managers tend to dislike them even more. The annual bloodletting ritual called evaluations is designed to find one's faults and shortcomings in a vieled attempt to encourage improved performance. This negative interaction destroys morale and hurts productivity. Learn a 21st-century  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...l health problems with managers and employees. Why you should attend: Rrisk of litigation if psychiatric disabilities aren't handled correctly, mental illnesses are one of the most treatable disorders but only a third of individuals who have them get help, this costs organizations millions of dollars each year, Areas Covered In the Seminar: How the ADA, FMLA and Workers' Comp intersect  more...

Document Retention and Destruction ...should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Coaching and Mentoring for High Performance by TrainHR ...hing and mentoring are critical skills that every manager should be engaged in order to develop the competence and confidence of employees. Great organizations achieve their full potential because they have exceptional people. But few people are born great. Nor are most people exceptional the day they begin work. They become high performers after they have been trained and given the  more...

Preventing Harassment in the Workplace by TrainHR ...of sexual harassment in the workplace. It will cover what should be in an effective Harassment policy, how it should be communicated, and who is held responsible for assuring compliance. Also included is handling complaints, documenting charges and conduct and addressing any situation that may be construed as harassment. It will also describe liability for the company and/ or its supervisors.  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR ...vey the desired practices in your organization. Policy should be reviewed and updated periodically and through this webinar you can review your current policies, clarify policies for easier administration, and perhaps add new policies others to address new situations and circumstances in your workplace. Well thought out and clearly written HR policies provide comprehensive, consistent  more...

HR Metrics for the Human Resource Executive by TrainHR In this webinar we will discuss measurements and ratios that will be meaningful to the Human Resources Department and the Executive Team in determining successful use of human capital. Human Resources uses both left and right brain thinking to achieve its objectives and key metrics for both will be covered. We will also give you practical ongoing measurement tools that should apply to all types  more...

How to Conduct an Offensive Behavior Investigation by TrainHR This program will help you understand how to conduct discrimination and harassment investigations. Learn how to avoid the legal pitfalls of conducting discrimination investigations. Learn how flawed investigations can cause nightmares for employers. Understand when you need to call in a professional to conduct your investigation. Receive updates on the most recent cases on these issues and  more...

Emotional Intelligence What it is and Why it Should Matter to You by TrainHR The most important "e-term" you may learn in 2011 is emotional intelligence. Experts say it can make or break careers and elevate executive leadership to higher levels of success, so what are the best moves and worst emotional pitfalls you can make? Learn from executive coach and nationally acclaimed author Arnold Sanow what it is and why it matters to the success of executives and the companies  more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen ...w approach to these key and related documents. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too  more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean ... Lean Configuration to this key part of a QMS. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in controlled documents - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documentation and not  more...

Document Retention and Destruction by TrainHR ...should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Understanding and Implementing USP 1058 Analytical Instrument Qualification - Webinar By GlobalCompliancePanel ...should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...!) as they apply to the pharmaceutical laboratory. Why Should You Attend: Discover what the FDA and EU regulations say about documentation Learn what your signature and/ or initials mean on a document See how to handle and manage data entry and errors Review "Do's" and "Don'ts" of documentation practices Discuss rounding and limit expression determinations  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...e FDA and the Notified Body will be discussed. Why you should attend: Increasingly U. S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...olicies needed and identify the topic areas that policies should include, making it easier to deal with the dozens of policy details that are required. Areas Covered in the Session: * Find out what are the requirements for policies and procedures and why they're a good thing. * Learn how having good policies and procedures and good documentation can make compliance easier. *  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...HIPAA and PCI rules and what are the ways the information should be protected, including the safeguards called for by HIPAA and PCI. They will learn what are the consequences of not protecting health and payment information and what to do if their information security is compromised. We'll talk about strategies to limit exposures under PCI and HIPAA, and what steps can be taken to help limit  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...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 device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the ICH processes and why the Sponsora ™s / CROa ™s Monitors are so important.  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...agnosis and treatment of patients more consistent. Why Should You Attend: Process Validation (PV) has been a widely discussed and debated "phenomenon" in FDA regulated industries for many years. Do you know what process validation is and how you would explain it to an "alien" from another industry? Now, this is not to mean that other industries do not practice process validation because they  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...l 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 requirements, what are the key contractual  more...

Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel ...hical, moral, and legal expectations from the FDA. Why Should You Attend: The webinar is designed for mid-level Quality Engineers and Quality Engineers who design and manage the Quality system. What you will learn: * The CAPA definition * the CAPA LIFE cycle * Tools for each CAPA cycle * CAPA requirements * Tools for Preventive Action * Common FDA CAPA  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...ement 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 control of  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...fire fightinga and minimize compliance problems. Why Should You Attend: Expectations for meaningful, results driven root cause analysis that addresses and resolves underlying product problems are increasing among regulatory agencies world wide, with good reason. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...ed. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may  more...

21 CFR Part 11 How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel ... 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 and more of the computer technologies. Part 11 is a regulation that regulates the technology when it comes to electronic signatures and electronic records and will be more  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...ory, system audits, CAPA and remediation programs. Why should you attend: "Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site? Areas Covered in the Session: * 21CFR Part 11 Compliance * Review of  more...

Key Factors to Write an Effective Standard Operating Procedure SOP and Work Instructions WIs - Webinar By GlobalCompliancePanel ...rk instructions and Standard operating procedures. Why Should You Attend: The current shift in FDA thinking is that manufactures do not give their employees enough direction to perform their jobs. This thinking is reflected in many warning letters that written to organizations by several FDA field offices. The problem is compounded by the confusion in the pharmaceutical, Biotech, and Medical  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...evice Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you maintaining  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel ...emely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...match the V&V process to the product and risk. Why you should attend: * Whether you're planning to audit an internal IT system, anticipating an audit from a customer, preparing for the inevitable FDA inspection, or a vendor wishing to clearly demonstrate a software product is Part 11 compliant, this teleconference will give both old hands and new staff the practical information needed  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ...a risks and preventing potential HIPAA violations. Why should you attend: Attendees will learn what their risk analysis and security analysis obligations are under HIPAA and the new "meaningful use" rules under the HITECH Act. Attendees will receive questionnaires and checklists that can be adapted for use by a healthcare provider to conduct a targeted risk analysis and meet HITECH and HIPAA  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...at will be required to maintain a validated state. Why should you attend: If cloud computing is so potentially important and valuable, why is it so feared? The biggest fear in regulated industries is maintaining a compliant system that is not fully controlled by the client, since the vendor is in possession of servers and software. Cloud computing is cheaper in the long run, but the quality  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...hey are based on the notion that everything in the sample should pass inspection. The course examines these plans using the curves described above. The OC curve, in these plans, has a different shape that can lead to problems. We will discuss the following issues: * How to use the c=0 plans instead of Z1. 4 plans * The basis for the plans using the RQL point * The differences  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...etween the master and the batch production record. Why should you attend: All the requirements for the master production record (MPR) are based on relevant US and EU regulations. Failure to recognize and implement those requirements can have devastating effects on your company's quality system, including production and manufacturing controls. The purpose of this webinar is to provide  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ... When deciding on whether or not a Test Management Tool should be implemented, companies need to realize that the implementation of the Tool will be similar to an implementation of any regulated application, therefore all applicable SDLC documents, vendor audits, validation/ qualifications, operation/ support, training and general use of the Test Management Tool must be considered, prior to  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...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 investigators as well as  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...trates 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. * Minimize nonconformances.  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...nderstand industry standards in cleanroom 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  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...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 time, it is a frequently  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ... o What are the components of an FMEA? * How should I use FMEA in performing risk management? * What are the problems with FMEA in risk management? * How is an FMEA conducted o What and who are needed o Identifying significant risks o Development of mitigating actions * Discussion of specific elements of an FMEA * Follow up  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...to ISO 9001 and FDA & European Union requirements. Why should you attend: International interest in certified quality systems is increasing. A Many foreign countries are now requesting medical device firm's supply them proof of certification to ISO 13485: 2003. To apply a CE mark under the Medical Device Directive, 93/ 42/ EEC, certification to ISO 13485 is required in most cases. This  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...d!) as they apply to the pharmaceutical arena. Why you should attend: The Learning Objectives of this presentation include: * Discover what the regulations say about documentation practices * Learn what your signature and/ or initials mean on a document * See how to correct errors and omissions in data entry * Learn "Do's" and "Don'ts" of documentation practices *  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...ansition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry through the implementation of a regulation - the Quality System Regulation (QSR), 21CFR820, in 1996. It is not clear when  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...ird party (CMO) manufacturing, 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  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ...ull compliance with the security requirements. Why you should attend: Understanding DEA regulations is important and the steps suggested in this training will give you a better insight as to what steps should be taken to prevent the illicit use or diversion of any controlled substance by hospital staff. What the presentation does is that it gives participants a better understanding of Due  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...used in FDA or equivalent 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  more...

Overall Residual Risk Evaluation - Webinar By GlobalCompliancePanel ...ill be an important part of this presentation. Why you should attend: One of the most important Risk Management activities is the Overall Residual Risk Evaluation which occurs at the end of the development cycle to assure the product risk meets the risk acceptability criteria prior to issuing the Risk Management Report and release of the product. Companies have not had methods in place to  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel ...dvance for certification 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  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ent planning in divided management structures. Why you should attend: One of the major requirements of the medical device risk management standard ISO 14971 is to develop a Risk Management Plan. One of the least understood and executed requirements are the Risk Management Plan. As ISO 14971 becomes required for product safety certification and is audited by regulators this requirement will  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...lement fields will find it informative and useful. Why should you attend: FDA has stated that the principles in the new guidance are directly supported by regulation, law, and current best practices, and expects to begin issuing 483s immediately. While the medical device industry has been subject to many of the requirements in the new guidance, most pharmaceutical firms and their suppliers  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ... comprehensive and compliant investigation system. Why should you attend: Inadequate failure investigations continue to be a major GMP deficiency cited during routine and "for-cause" inspections conducted by the FDA. While the FDA recognizes that failures are a part of business, it expects comprehensive investigations of those failures, the application of scientific judgment and sound  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...ct recruitment brings and discuss the strategies that you should consider. You will also learn the reasons subjects do and do not participate in clinical trials and why the recruitment phase of a clinical trial is so important. The importance of a good "Recruiting and Community Relations" department eliminates failure as a option. Why should you attend: Because of the importance of on-time  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ...rom a variety of different analytical instruments. Why should you attend: Everyone who works with analytical data is working with a calibrated measurement system. However, few people really understand the principles and assumptions behind the calibration methods used for their instruments. As a result, we often make mistakes, generate poor quality data, or perform additional experiments that  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...or each design stage will be included as well. Why you should attend: Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. You need to be aware of how design control applies to your device(s). It's apparent many firms are not: inadequacy of the design control system was cited on almost half of the Warning Letters  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...ocess validation, explaining how, when, where and why one should validate. Participants will learn how to comply with FDA and international regulations for validation protocols. Attendees will also learn how to maintain adequate validation documentation systems and perform equipment qualifications and process validations, and evaluate the need for re-validations. Why you should attend:  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ... your companya ™s ongoing quality system. Why you should attend: If you don't know what the FDA inspector is going to look at when (s)he performs his/ her audit, how can you really know what to prepare for? Even a thorough internal audit may not focus on the areas that the FDA inspector will. The most effective way to increase the likelihood of your internal audits identifying issues  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ... options to many of the most common practices. Why you should attend: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel ...e webinar and again at the end of the webinar. Why you should attend: Pre-approval inspections provides a relatively narrow window of time during which the NDA/ BLA/ ANDA holder can demonstrate to the FDA that the quality systems at the site are in compliance with the GMPs and that appropriate facilities are available to support manufacture of the product. It is therefore important to  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ...&A halfway through the webinar and at the end. Why you should attend: FDA inspectors have in the past identified OOS Investigations as the leading cause for concern in Pharmaceutical laboratories. A review of the Warning Letters issued in the past year shows that OOS Investigations continues to be among the most frequently cited area. The Investigation system will therefore continue to  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...ical for GMP/ GLP compliance will be reviewed. Why you should attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment Program is also an expectation in GLP and GMP laboratories. Areas Covered In the  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ... * Create and use a recall operational procedure and what should it contain * Understand what are effectiveness checks * What happens in a medical device recall and your responsibility * Learn why a recall is either a correction or a removal depending on where the action takes place * Understand what is required for the recall strategy as expected by FDA * Medical  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...he types of materials that can be distributed. Why you should attend: This presentation will address both the regulatory and products liability consequences of off-label promotion. It discusses the fundamentals of off-label promotion and provides risk management tips to help companies prevent off-label promotion. Areas Covered In the Seminar: * Off-Label Use of Drugs *  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ... or cutting adrift such regulatory "partners". Why you should attend: The last few years have seen the U. S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based. Most  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...and approval, while reducing liability issues. Why you should attend: The U. S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time.  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...l areas of a companya ™s cGMP activities. Why you should attend: The last few years have seen an increase in product recalls. For this and other reasons, the U. S. FDA has come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ... to prove to the FDA that known company cGMP deficiencies should not be a major concern to the Agency, and which may 'eliminate' the possibility of a deserved Warning Letter. Why you should attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways of doing things is not acceptable. The Agency continues to use high-profile cases  more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel ...e shattered so many personal and professional. Why you should attend: To avoid repeating the painful failures in risk management that occurred during the global financial crisis of 2007 to 2009 (also known as the great recession), it is essential for today's business, IT, risk, compliance, and audit managers to understand the big picture of risk management to accept that risk management goes  more...

Information Security - Overview Information security means protecting information and information systems/ assets from unauthorized access, use, disclosure, disruption, modification or destruction. Every individual who deals with information should have a better understanding on how to safeguard his/ her personal or company's data. This session will assist partcipants to 1. Understand WHAT, HOW & WHY of information  more...

WorkPlace Skills A set of skills that are essential to success in the work life. These are very basic and fundamental skills one should possess to be successful in job selection or to succeed in his/ her work atmosphere. 1. Email and Telephone etiquette 2. Using MS Excel 2007 / 2010 3. Using MS Word 2007 / 2010 4. Using MS PowerPoint 2007 / 2010 5. Using emails - Webmails, Outlook etc., 6.  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...ectronic records and the current guidance document Why should you attend: FDA Inspections are based on ensuring compliance with the regulations. Failure to comply can result in the FDA citing the company for a violation, i. e., listing it on an FDA Form 483 Inspectional Observations. The FDA may even escalate these observations to a Warning Letter. Unfortunately, many well meaning intentions  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ... * Achieve synergy among control programs Why you should attend: Manufacturers of human medical products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal  more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel ...rk and rejections * Avoid product recalls Why you should attend: Regulatory agencies expect manufacturers to periodically demonstrate that cleanrooms and controlled environments perform according to their design specifications. In addition, periodic testing confirms the efficacy of maintenance and process controls. It is the responsibility of the Cleanroom owner to maximize the value of  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and control limits are introduced and explored as tools for performing process validation. Why should you attend: Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...result in an overall Part 11 compliant deployment. Why should you attend: With the announcement in 2010 of a new Part 11 Inspection initiative, life science organizations can expect to see a higher level of scrutiny of the compliance of computerized systems utilized for regulated activities. To avoid any regulatory observations on your automated systems, it is important to ensure that  more...

International Financial Reporting Standards The Basics - Webinar by GlobalCompliancePanel ...egun 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 change * What will not change * Who needs to  more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel ...rated from many different kinds of test equipment. Why Should You Attend: Most people hate statistics, because they don't understand statistics. If you either generate or review laboratory data, you will want to attend this seminar. We will discuss the basics in a way that doesn't involve lots of jargon and complicated equations. We use real world examples and common spreadsheet functions to  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...nd learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you with enough ideas, suggestions and HOW TOs that you and your teams and  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ... 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. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and  more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel ...eprocessing & validating reusable medical devices. Why should you attend: Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...uirements to plan and drive the validation effort. Why should you attend: With the FDA announcing that it will be performing Part 11 audit this year and the FDA currently inspecting and issuing warning letters to companies that have violated PDMA requirements, it is important to understand what the requirements are and how to ensure compliance with them. Noncompliance can cost companies  more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel ...packaging, and claims made on e-commerce websites. Why should you attend: * Avoid product recalls * Be in compliance with labeling requirements * Avoid wastage in regulatory fines * Improve your profitability Areas Covered in the Session: * Labeling defined * Current compliance labeling issues * Labeling requirements * How to design a labeling  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...enting the 510(k) submission (or 'not') rationale. Why should you attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and ita ™s effect on regulatory review activities are not  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...sary changes, in a realistic, risk-based approach. Why should you attend: Pressure is increasing on the FDA to get tougher on industry. The FDA has responded. * How does that impact companies' use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing? * How can this be addressed? * What does "science-based" mean? *  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...hance of recalls, and an improved bottom line. Why you should attend: The FDA expects companies to manage projects formally - to include regulatory requirements, design and/ or change control, with consideration of all applicable standards. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...derations to make GMP training more effective. Why you should attend: Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological products. Documentation is also needed as evidence that the training occurred. More and more frequently, regulatory agencies  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...al media policy that meets these requirements. Why you should attend: Some healthcare providers want to engage social media marketing, but are afraid of the risks. Some are active in social media, and are not aware of the risks. And some simply need to ensure that they are focusing on the correct risk areas and structuring their social media activities in ways that allow them to effectively  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ... the maximum benefit and score from the audit. Why you should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits. Without passing scores on these audits, companies are losing current accounts and are denied access to new accounts and business. Many organizations are new to the process of audits and  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ...rsonnel to meet program training requirements. Why you should attend: Recalls for chemical contamination can be costly to an organization injuring consumers and damaging the brand and its sales. Hundreds of opportunities for accidental and intentional contamination can occur in even the best operations. Proper chemical control can minimize risk, resulting in better risk ratings and greater  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ... system will be explored. FDA indicates that CAPA systems should be risk-based. The presentation will give an example of how to develop a risk-based CAPA system. Why should you attend: In reviewing FDA Form 483 inspection observation reports and Warning Letters which are published on FDA website, we find CAPA cited in most cases. CAPA has been part of FDA regulations on the medical device  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...e will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification 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  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...derations 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 in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of foreign sites is appealing to all drug developers, especially generic and 505(b)(2). Due  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...nners, cell phones, and portable data devices. Why you should attend: The HIPAA Security Rule, in place and as proposed in amendments going into effect in 2011, calls for all Covered Entities and Business Associates, and their subcontractors, to be in compliance with provisions protecting all kinds of electronic protected health information. While many entities have gone through the  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...d to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ... upcoming requirements for manufacturer reporting. Why should you attend: Medical device manufacturers continue to have problems with the MDR regulations and reporting of potential adverse events and possible device malfunctions. The regulation has been unchanged for several years, but FDA continues to find violations of these regulations. Both large and small manufacturers have been cited  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...ability to assess and improve its own systems. 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 material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ... regarding how to reduce supplier risk levels. Why you should attend: Management from any food handling company interested in learning a basic thought process that will help them to reduce the risk of being caught in a food recall should consider attending. Which food suppliers represent high risk? Which ones are likely to cause an outbreak associated with E. coli or salmonella? Should your  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...nsors, 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 an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...ory compliance and data quality will be discussed. Why should you attend: The analytical instruments and laboratory equipment are easy targets for inspectors looking to cite observations of non-compliance. Are yours ready for the internal QA and external regulatory inspectors? Areas Covered in the Session: * Regulatory requirements for analytical instrument qualification *  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...iences designing and implementing quality systems. Why Should You Attend: Many quality professionals fear the FDA because they perceive the regulations to be very structured and at the same time open for interpretation. They further perceive the FDA as being the experts interpreting the regulations. It is true that the FDA establishes policy for enforcement of the regulations. It should be  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... * 510(k) Frequently Asked Questions * Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session Who will benefit: This course is appropriate to those involved in all aspects of the premarket notification, i. e., 510(k) process on behalf of medical device and In Vitro Diagnostic  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...evice Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ... will discuss how disclosures must be tracked. Why you should attend: The HIPAA Privacy and Security Regulations have been modified by language in the HITECH Act within the American Recovery and Reinvestment Act of 2009 and the resulting changes in the regulations issued as interim final rules (IFRs) and notices of proposed rule making (NPRMs) by the US Department of Health and Human  more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel ...d 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 material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...o be considered when determining whether a tracking order should be issued * Understand why tracking methods are subject to FDA inspection * When does tracking end? * Identify what information to report and your responsibilities * Understand the impact with user facilities and patient issues Who Will Benefit: This webinar will provide an overview and guidance to device  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...cal research. TO not follow the protocol is folly. Why Should You Attend: Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed. Areas Covered in the Session: * How to know when the protocol is not followed (PNF)?  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ...t corrections, and provides recommended practices. Why should you attend: 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. If not, FDA's sanctions could be so onerous as to result in the company's inability to ship  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ...her 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 real issue and suggest actions to prevent similar observations in other  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...ons to the Agency, and in any remediation efforts. Why should you attend: Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. To add to the urgency, there has been a major shift in the emphasis of the U. S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response  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...

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 ... 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. It will provide background for OTC Drug labeling regulations and an understanding of how to comply with FDA requirements. Potential FDA enforcement actions  more...

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...tered so many personal and professional lives. Why you should attend: To avoid repeating the painful operational risk management failures that we have witnessed in such diverse organizations 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  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 This webinar will provide valuable guidance to regulated companies in development, 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  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...ire a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/ or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device descriptions, which would be available to the public on a revamped 510(k) database. In an attempt to keep up with the rapid  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel 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". 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"  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported  more...

How to Survive a DEA Audit or FINDFINE - Webinar by GlobalCompliancePanel ...all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel conducts an unannounced inspection of a pharmacy to perform an audit, they generally do not inform the DEA registrant on what steps will be taken during the inspection. In some cases, the pharmacist is not aware of what information they will need until they are asked by the investigators.  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...ose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel ...chniques and risk management. The rigor of a validation should be tied to the individual risk assessments of your products Critical Quality Attributes laid out in your design controls. Using the GHTF Process Validation Guidance document as a backdrop, this seminar will provide a review of the fundamentals of validation, provide guidance on using a risk classification scheme to define the  more...

Risk-Based Validation of cGMP Systems How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.  more...

Design Planning and conducting Effective audits GlobalCompliancePanel brings a new webinar on the topic of Design, Planning and conducting Effective audits. Webinar will be on March 23, 2010. Webinar will be presented by Mark Roberts. Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and  more...

Records Management 5 - Additional RM Program Components - On-Demand Webinar ...Management will look at the other program components that should be considered to develop an effective and efficient program. Topics covered include: vital records protection; choosing the right medium or mix of media for storing the records; scanning records; policies and procedures; privacy; placing records on hold for litigation; and managing offsite storage. Michael Oa ™Shea has been  more...

Records Management 3 - Retention Scheduling - On-Demand Webinar The third in the series of Records Management webinars covers retention schedules. Topics include what the schedule should include, how to gather the data, how to apply legislation and get approvals. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and emerging forms  more...

Records Management 2 - Developing Classification Schemes that are Used - On-Demand Webinar ... classification scheme really is, what a corporate scheme should include, how to develop one to gain maximum buy-in and how to apply and maintain it to ensure continuing effectiveness. Michael Oa ™Shea has been involved in Records and Information Management consulting for over 20 years. He is one of the most respected international experts in traditional and emerging forms of information  more...