GMP Webinar: Audit Trail Review

Thursday, 16 February 2017, 15.00 – 16.30 h CET

Course No. 16046

header-image

You can find all other dates of this seminar in this overview.

Speakers

Dr Wolfgang Schumacher
Dr Wolfgang Schumacher worked for ASTA Medica and F. Hoffmann-La Roche and has more than 30 years of experience in the Pharmaceutical Industry. After a successful career in Cancer Research he focused on the management of national and FDA inspections, auditing of contract manufacturers and the accountability as QP. At Roche he established the IT quality assurance department and was recently accountable in Technical Operations as Vice Director for the GMP/CSV compliance of all global computer systems and the setup of the Data Integrity program, for Genentech as well.

Background

The topic “data integrity” is at present one of the major focal points in national and international Health Authority inspections. The American FDA has found a significant number of deviations which were reported in warning letters in the last years. In addition to the assurance of product quality the authorities require from all companies a clear strategy how the integrity of critical data can be ensured over their entire lifecycle. The Review of Audit Trails plays a key role in this respect. Despite the various guidelines which were published after 2015 there is no clarity about the requirements for Audit Trail review and how it can be implemented in the daily business.

Target Group

The audience of this Webinar should be collaborators from QC, QA, production and IT, which are dealing with data integrity and the review of Audit Trails, are engaged as system administrators or manage computer systems in the GMP area.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

You will find the detailed system requirements in this document.

Programme

The Webinar aims to focus on the critical elements of data integrity and Audit Trail Review:

  • Regulatory Overview with emphasis on the requirements of MHRA and Annex 11
  • Classification of data – which are critical data?
  • Classification of systems – which systems are relevant?
  • What Audit Trails are of importance?
  • What shall I do with legacy systems without Audit Trail?
  • Who shall review Audit Trails?
  • How is it documented?
  • What process and documentation is appropriate in case of deviations?

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Additional dates on-site
Additional dates on-site
not available
icon
Additional dates online
Additional dates online
not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"I am so grateful for having attended this course. Great job from all, and very profitable. Thanks!”

Alba Aranda Cuesta, Kern Pharma
KPIs and Quality Metrics, Berlin, Germany, April 2025

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Both, organizers and lecturers were very friendly, open for discussions and extremely constructive. The course was a valuable experience for me.”

Maria Dimitrova, NKN Law Firm
Pharmaceutical Contracts: GMP and Legal Compliance, March 2025