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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 359

Implementing the New Final EU/PICS-GMP Annex 15 on Validation and Qualification 

New requirements and strategies for implementation

Recorded, available with all reference material at any time 

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The new final EU Annex 15 on Validation and and Qualification has been released on March 30 and has been adopted by PIC/S on April 1. The Annex has been significantly updated compared to the first version of 2001 but also compared to a draft version from 2014. The Annex is in line with other modern related documents such as ICH Q8/9/10/11 and has components from Quality by Design,  Risk Assessment and Quality Systems, for example, continuous lifecycle management, and continuous  verification and improvements. With the adoption by PIC/S the Annex will be expanded from EU countries to worldwide acceptance. Currently PIC/S consists of 46 participating regulatory authorities worldwide, including all EU member states, but also  the US FDA, Health Canada and many international agencies from Latin America, Africa, Asia and Australia. Both the EU and PIC/S guidelines take effect October 1, so now it is a good time to learn about the Annex.

Key Questions related to the new final Annex 15

  • What are the new requirements of Annex 15 compared to the 2001 version?
  • What are the differences to the draft version from 2014?
  • What is the difference to the EMA process validation guidance
  • What exactly are the expectations of inspectors?
  • The new Annex does not require to apply the Quality-by-Design approach but refers to specific components, such as design space, critical quality attributes, and critical process parameters, so what to do?
  • Can we still use the 4Q qualification principle as required in the  2001 version and USP 1058?
  • What should be included in the validation master plan?
  • When Do we need individual project plans?
  • What exactly should be in each qualification phase: URS, DQ, FAT/SAT (factory/site acceptance testing), IQ, OQ, PQ?
  • When do FAT/SAT need to be performed?
  • What and how much should be tested in the DQ, IQ, OQ and PQ phases?
  • The guide requires FAT/SAT, how does this relate to the 4Qs?
  • The Annex does not mention retrospective validation of existing systems, so what to do?
  • What are acceptance criteria for equipment and cleaning validation?
  • Does the Annex recommend traditional process validation, and if so, how many batched should be used?
  • What to do when the equipment and processes are changed?
  • How to deal with new requirements such as packaging, utilities, transportation and analytical testing methods?
  • How to implement the Annex most effectively?

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 an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • Legal basis and time table for implementation and enforcement
  • Difference to the 2001 version
  • Differences to the draft version from 2014
  • Scope and general requirements
  • Organization and planning for qualification and validation
  • The importance and contents of a validation master plan
  • Qualification steps: URS, DQ, FAT/SAT IQ, OQ and PQ
  • Steps for factory and site acceptance testing (FAT/SAT):
    who does what and when.
  • Acceptance criteria for equipment and cleaning validation
  • Process validation: general requirements, concurrent validation, traditional approach, continuous process verification
  • Ongoing process verification during lifecycle
  • Validation and qualification of existing systems and processes
  • Ongoing review and requalification of equipment
  • Validation and qualification of utilities, transportation, packaging and analytical methods
  • Cleaning validation
  • Change control and requalification after changes
  • Recommendations for effective implementation
  • Documentation requirements

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

  • Validation master plan: Template and examples
  • Checklist: Validation and qualification according to the new Annex 15
  • SOP: Qualification of equipment
  • SOP: Requalification of equipment
  • SOP: Equipment maintenance
  • SOP: Change control of equipment
  • SOP: User Requirement Specifications for equipment
  • Annex 15: Version 2001
  • Annex 15: Version 2014
  • Annex 15: Version 2015 (final), adapted by PIC/S
  • Slides of the presentation as PPT files to train others
  • Script of the presentation
  • All questions and answers from before, during and after the seminar

Qualification Steps According to the new EU-GMP Annex 15


Attend the seminar to learn detailed requirements for each step and requirements for the validation master plan and the validation report

Who should attend?

  • Operation managers and staff
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
  • Validation specialists

Date, time and duration

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.


. 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 explained FDA's next 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,