Audio Seminars

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All seminars come with 10+ best practice documents, such as SOPs, checklists, master plans

 

Electronic Records

 

Understanding and Implementing the New Final EU Annex 11

Learn about specific requirements and get tools for implementation

Recorded

 

Understanding and Preparing for FDA's New Part 11 Inspection Program

With 10+ Best Practice Guides for Easy Implementation

Recorded

Recorded

Learning from Recent Warning Letters and 483's Related to Computer Validation and Part 11

With Case Studies to Avoid and Respond to 483's and Warning Letters

Recorded

 

Electronic Raw Data in Regulated Environments

Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance

Recorded

 

FDA's 21 CFR Part 11

Introduction and Strategies and Tools for Implementation

Recorded

 

Cost Effective Electronic Data Archiving for FDA Compliance

Understanding and Implementing the New GAMP Guide

Recorded

 

Electronic Audit Trails for FDA Compliance
Requirements - Design - Implementation - Validation - Documentation

Recorded

 

FDA Compliant Electronic Records Management

Recorded

 

Using the SAFE Standard for Digital Signatures

For legally enforceable IP Protection, Electronic Transactions and FDA Submissions

Recorded

 

Auditing Computer Systems for Part 11 and Annex 11 Compliance

Prepare your organization for upcoming FDA and EU inspection

Recorded

 

 

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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On-line Audio Seminar 271

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded, available with all reference material at any time

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Periodic Evaluation and Review of critical computer systems assures that the system is operating within its validated state. The FDA expects a periodic evaluation and periodic evaluation of computer systems became a legal requirement for the European market after July 1, 2011. Chapter 11 of the new EU GMP Annex 11. However, companies are unsure how to conduct and document periodic reviews.

Key Questions related to Evaluation and Periodic  Reviews of Computer Systems are:

  • There are FDA waning letters about missing periodic review, what is the legal basis for this?
  • What are exact FDA and international requirements?
  • What are the benefits of periodic evaluation and review?
  • Why should we do reviews, we have validated our system and follow procedures for changes?
  • Does periodic review substitute regular revalidation?
  • What is the recommended frequency reviews: 3, 6, 12, 24 months, or more?
  • What events trigger periodic review, change control, system failures, others?
  • Where to get inputs for periodic inputs?
  • Who is responsible for regular evaluation and periodic review?
  • What is the difference between gap analysis and periodic review?
  • What should we look at for evaluation and reviews?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international regulations and guidelines
  • Inspection and enforcement practices
  • Purpose and objectives of the evaluation and review
  • The role of periodic evaluation and review vs. internal audits and gap analysis
  • Developing an SOP for evaluation and review
  • Responsibilities, tasks and owners
  • Frequency and timing of evaluations and reviews
  • Criteria and justification for frequency or review vs. revalidation
  • Inputs for reviews
  • The review process from planning to documentation
  • Corrective and preventive action plans
  • Documentation for the FDA and other agencies

And for easy and instant implementation:
download 10+ documents from special seminar website

  • PowerPoint Presentation
  • Script
  • SOPs
    - Periodic Review and Evaluation of Computerized Systems
    - Change Control of Software and Computer Systems
    - Configuration Management and Version Control of Software.
  • Checklist: Periodic Evaluation and Review of Computerized Systems
  • Forms and blanks
    - Documenting Deviations of Computer System Reviews
    - Documenting Corrective Actions of Computer System Reviews
  • Warning letters and/or Inspectional observations related to computer system validation
  • Others

Who should attend?

Industry

  • Pharmaceutical development and manufacturing
  • Biopharmaceutical development and manufacturing
  • Medical device
  • Blood testing/Clinical testing

Functions

  • IT managers and system administrators
  • QA managers and personnel
  • QC and Lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants

Date and time

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,