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All documents shown here are included in the seminar for instant download

Edwin Rivera
 Data Integrity and Fraud - An Other looming Crisis

Steve Wilson:
FDA Regulatory Perspective on Data integrity

 

Warning letters and Inspectional observations related to raw data and other electronic records

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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For feedback on Dr.Ludwig Huber's Part 11 related seminars, click here

On-line Audio Seminar 384

Understanding the New FDA Guidance: Data Integrity and Compliance with cGMP

With examples and procedures for effective implementation

Recorded, available with all reference material at any time

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In recent years, FDA has increasingly observed CGMP violations involving data integrity lapses during CGMP inspections. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. The new draft guidance answers 18 questions related to data integrity for cGMP compliance. The guidance also. clarifies the following terms as they relate to CGMP records: data integrity, metadata, audit trail, "static" and "dynamic" record formats, backup, and "systems” in “computer or related systems”. Based on the presenter's experience from previous seminars more questions are expected:

Key Questions are:

  • Are there examples for computer systems as defined in the guidance?
  • Can you recommend an SOP for handling dynamic records as defined by FDA
  • Are there more examples for static or dynamic records?
  • Which computer systems require validation?
  • Does this guidance replace to "Part 11 Scope and Applications Guidance" from 2003?
  • Under which circumstances can I delete the electronic records after I have printed and signed the paper records?
  • FDA requires availability of 'complete' records, what does this mean?
  • How to define raw data and meta data vs. data?
  • How to best demonstrate data integrity and security?
  • Is e-audit trail still under enforcement discretion and what does this mean?
  • FDA requires reviewing electronic audit trails. Who should to this, when and how should it be documented?
  • How important is risk assessment for managing data integrity data, are there examples?
  • I scan paper  and store PDF files in a data base - is the scan an accurate copy of the paper?
  • The EU/PICS Annex 11 requires indicating changes of raw data on print-outs, how can we do this, is this also recommended by FDA?
  • Should I be able to reprocess the electronic raw data and if so for how long?

How does the this 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 and case studies. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation of the principles and strategies.

During the interactive presentation you learn about: 

  • Background and scope of the new guidance
  • Comparison with the Part 11 guidance from 2003
  • Definition and examples of data, raw data and met data
  • Definition and examples of static and dynamic record formats
  • The meaning of ALCOA and ALCOA+ components
  • Requirements for electronic audit trail
  • Review of electronic audit trail review: who, what, when and how
  • The FDA meaning of 'backup' vs 'backup copies'
  • Examples for 'computer or related systems' as defined by FDA
  • Workflow validation of computer systems for its intended use
  • What to do if the 'record' owner is also the system administrator?
  • Controlling blank forms by the quality unit
  • Procedure for using electronic records as a substitute for paper records
  • Procedure for using paper records as a substitute for electronic records
  • Procedure for using electronic signatures instead of handwritten signatures
  • Definition and examples for system evaluation samples, system suitability standards and actual samples
  • Handling internal integrity related tips, e.g., on data falsification
  • Handling data integrity problems identified during internal audits and FDA inspections

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

  • SOP: Integrity and Security of Electronic Data
  • SOP: 21 CFR Part11 - Scope and Controls
  • SOP: Electronic Audit Trail - Specification, Implementation, Validation
  • SOP: Review of Electronic Audit Trail
  • SOP: Retention and Archiving of Electronic Records
  • SOP: Manual Reintegration of Chromatographic Peaks
  • Validation example: Testing of Authorized System Access
  • Checklist: Security and Integrity of Electronic Laboratory Data
  • Checklist: Electronic Audit Trail
  • Checklist: 21 CFR Part 11
  • FDA Presentation: Data Integrity and Fraud – Another Looming Crisis?
  • Literature Reference papers.
    - Implementing 21 CFR Part 11 - Data Migration and Long Term Archiving for Ready Retrieval
  • Warning letters and Inspectional observations related to data integrity and security

Who should attend?

  • Everybody who creates, reviews and approves regulated electronic records
  • Pharmaceutical and Device Manufacturers
  • API Manufacturers
  • Contract Organizations providing services for GxP compliance
  • Documentation professionals
  • QA/QC managers and personnel
  • IT professionals
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • 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,

 

Testimonials/References

 

 

The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

  1. Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback:
    The seminar did meet my expectations.  I always expect a wonderful seminar from Dr. Huber, and my expectations were once again met. A great time saver for me as I do not have time to look up recent 483s relating to Part 11 -- worth the time and cost.
    Ms. Diana Mayes, Manager of ABC Laboratories, USA
    (Ref T-1077)
  2. Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11
    Feedback:
    The seminar did exceed my expectations.  The presentation contains much more pertinent information than I had expected.
    Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany
    (Ref T-1076).
  3. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  The seminar is very useful as it contains a lot of information.
    Mr. Lucian Hirtie,  QS Manager, Labstat International ULC, Canada
    (Ref T-1082).
  4. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  Very informative presentation, and clearly presented . Dr Huber does an excellent presentation, well developed, and very informative, as usual.
    Mr. John Egoville,  Senior Compliance Auditor,  Computer Validation Group, TEVA Pharmaceuticals, USA
    (Ref T-1081)

  5. Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback:
    The seminar exceed my expectations.  Webinar was very informative to our current practice and will help us focus and stream line our process. I would recommend this seminar to everyone having the same responsibilities.
    Ms. Mike Robertson, QA Engineer at Energizer, USA
    (Ref T-1078).