Address Web-based Seminars

Data Manipulation Techniques ...SAS, txt, dat., excel, use the ODBC, etc); Clean data and address such issues as missing data, duplicate entries, outliers; Reshaping, aggregating, merging data; Performing such tasks as looping, vectors, beginning automations with macros specific to data manipulation. Primarily syntax will be used, but where helpful to those learning syntax, some GUI interface will be utilized as well.  more...

Call Center Social Media Certification - Live Online - May 9-11 2012 Social media represents one of the most significant changes in consumer media behavior in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring  more...

Managing Difficult People Training ...ging Difficult People training course teaches students to address difficult people according to their specific behavior. Students will have the opportunity to meet with several Marketing Department team members to address their difficult personalities, follow the guidelines for managing difficult people to decrease the department ' s turnover rate and meet the release date for a new product.  more...

Comprehensive JSP Training ...give JSPs a simple, powerful framework by which to parse, address and transform XML data using XPath and XSLT. Each individual tag in each library is covered, with precise syntactic rules shown in a standard format in the student guide, and JSTL techniques and best practices are discussed for each library. An extensive set of example applications illustrates common usage of each major  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...

A Better Method for Cross Training Production Personnel ...nufacturing 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 others. a How to get employees to certify the skills of other employees. a Building  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing ...iors. Specific performance measurement issues we will address in this montha ™s important a Global Manufacturing Enterprise Seriesa webinar include: - What is the best way to organize the procurement function when so many items are sourced globally? - How to define purchasing behaviors to better leverage global supply-chain opportunities. - Ideas for building a Global  more...

Understanding Improving Yields Scrap Rework ...and monitored will be demonstrated. Specifically, we will address: - How to PROPERLY measure yieldsa why is a yielda different from scrap? - How to PROPERLY measure and account for scrapa what does scrap REALLY cost? - Why yield and scrap metrics should NEVER be confused. - How to segment and quantify rework activities. - Trade-offs between scrap and rework... when is  more...

How to Conduct an Effective Monthly Variance Review Meeting ...manager is often in how operating variances are routinely addressed and how corrective actions are routinely executed. Great plant managers always conduct a routine a Variance Review Meetinga each month, challenging their direct reports to explain all significant variances from plan. These variances are usually, though not always, stated in terms of dollars. Specific variance that great  more...

A Better Method for Rationalizing Capital investmentsTools for Calculating REAL Investment Value It is an interesting observation that manufacturers continue to struggle with the best way to rationalize new investments in capital equipment. Interestingly enough, this struggle is often the result of failed cost accounting systems and methods. It is these systems that fail to provide accurate information that ultimately allow an investment to be appropriately modeled within the context of the  more...

Demystifying the Calculations of Efficiency Utilization and Productivity ...ciency and productivity. This 1-hour FREE webinar will address these three terms, demonstrate how to calculate each and describe where they are used in a manufacturing enterprise. With the demonstration of the formulas, we will explain how values derived from the formulas can be altered and how companies can benefit from the CORRECT understand of these terms. We will clearly show  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. Tuesday, June 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

RAPS Approved Seminar on Risk Management in Medical Devices Industry at Mumbai Overview: The course will introduce the main elements of risk management and the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management  more...

RAPS Approved Seminar on Risk Management in Pharmaceutical Industry at Mumbai ...address the processes, methods, and tools associated with Quality Risk Management. It highlights the disciplined environment that is necessary for proactive decision making to continuously assess what risks a organization is exposed to, which risks are important to deal with and how the implementation of strategies can mitigate risks. Additionally, the course provides trainees with skills to  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...

Master Production Record Requirement - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Using Statistics in Compensation - Webinar By TrainHR This webinar will address the statistics behind pay program design and administration, from the design of pay structures through the analysis of pay survey data. It will explore how practitioners create and analyze pay ranges, pay survey data, individual and group pay rates, and other elements of a compensation program.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...ncreased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable cGMP Part 11 software validations. The FDA and other regulatory  more...

Using Statistics in Compensation BY Train HR This webinar will address the math behind pay program design and administration, from the design of pay structures through the analysis of pay survey data that enables practitioners to create and analyze pay ranges, pay survey data, individual and group pay rates, and other elements of a compensation program.  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...he responsibilities of employers. This practical workshop address both the legal and psychological issues that often arise, such as confidentiality, fitness for duty evaluations, when and why to drug test, the relationship between conduct problems and mental illness, and how to directly address mental health problems with managers and employees. Why you should attend: Rrisk of litigation if  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR ...er 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 communication, reduce conflict , convey legal obligations, protect your company by covering employer rights, notify employees of recourse systems, clarify expectations, consequences and rewards,  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Master Production Record Requirements - Webinar By GlobalCompliancePanel ...address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There  more...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel ...t 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 corrective action  more...

Analytical Test Methods Validation for GxP Laboratory Compliance FDA ICH and USP Requirements - Webinar By GlobalCompliancePanel This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a product or process step; and to match the V&V process to the product and risk. Why you should attend: * Whether you're planning to audit an internal IT system,  more...

Data Security Analysis for Healthcare Providers - Webinar By GlobalCompliancePanel ... or assess their vulnerabilities. This presentation would address ways to conduct a security risk analysis to meet the requirements of HIPAA and the "meaningful use" rules. It will also provide examples of checklists and questionnaires to assist in uncovering and correcting for data risks and preventing potential HIPAA violations. Why should you attend: Attendees will learn what their risk  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...nsiderations. Why should you attend: This webinar will address the benefits of implementing a Test Management Tool to manage the validation life cycle, considerations for the implementation project of a Test Management Tool, Test Management Tool Operation/ Maintenance requirements and Automated Testing considerations. Areas Covered in the Session: * System Based Test Tools vs.  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...se health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...ributed. 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 * Overview of Current Legislation and  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ... of services and products / components. How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven actions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive, companies need  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...ols. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its approach to product clearance 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  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ... the past. Rather than be caught unprepared, proactively address these trends, and start to address areas of known deficiencies. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate. We will also discuss proven methods to prove to the FDA that known company cGMP deficiencies should not be a major  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...cies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give 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  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...w to suit your procedures, work instructions and forms to address it * Module 2 o Examples of problem solving tools, management tools and measurement tools, which are great for identification of the true root cause(s) of the issue o These tools also used for corrective actions, for most optimal definition of the improvement, for preventive actions o Visual  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...nal auditing for Part 11 compliance. This webinar will address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails - especially since Audit Trails play major role in Part 11 compliance - they can be your best friends and/ or  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ...ts on healthcare industry participants. This seminar will address the social media environment applicable to healthcare practitioners, the relevant restrictions, the sources of risk, and methods to form a social 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  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ... of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of deviations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...sign Controls. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: * Know the differences between the Traditional, Special and Abbreviated submissions * Understand Substantial Equivalence and how it is applied * Who is required to submit the application to FDA * Where to submit the 510(k) and what to expect with  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...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...ce used outside a device user facility. This session will address the latest FDA guidance requirements and expectations and expound on why tracking methods must provide certain critical information about the location of a tracked device. Plus, FDA understands that manufacturers will have different tracking methods and procedures. Areas Covered In the Session: * Review the key  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...ng to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the 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  more...

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

Introduction to Operational Risk - Webinar By GlobalCompliancePanel ...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 into the two most critical elements of  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..."  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel ...health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...ance. We will also explore risk causing events and how to address them. A review of risk severity/ level will then ensue. Upon completion of risk part of the presentation we will define what a CA/ PA system would look like. Finally an overview of a CA/ PA system will be presented and a CA/ PA approach will be proposed. The approach will focus on defining the specific steps to be taken when  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis  more...

Important Sterilization Information for Product Developers - Webinar by GlobalCompliancePanel Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers and Product Developers to aid them in the  more...