Pre-Conference Session to the 27th APIC/CEFIC Global GMP & Regulatory API Conference - in Vienna or online

22 October 2024, Vienna, Austria

Course No. 21236



Francois Vandeweyer

Francois Vandeweyer

VDWcGMP Consulting

Marieke van Dalen

Marieke van Dalen

MARA Consultancy, The Netherlands


This Pre-Conference Session provides an overview of the regulatory and quality GMP requirements and approaches for
implementing API Process Knowledge in the pharmaceutical industry. During interactive sessions you will get to know:

  • Which GMP and regulatory aspects have to be considered for establishing an adequate Change Control Management?
  • What do the guidelines tell us for reprocessing and reworking? And what are the practical consequences during the production of APIs?
  • What has to be taken into account when implementing control strategies?

Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion.
This Pre-Conference Session ideally complements the following 27th APIC/CEFIC Global GMP & Regulatory API Conference.


The API world is changing rapidly. Nowadays, Process Knowledge is one of the most important topics in the API industry. Companies
are struggling with the challenge how to implement and how to obtain Process Knowledge and ensure the quality of their products
during their life cycles. On the one hand, for that matter the theoretical obligations need to be considered and well known, while on
the other hand the practical implementation needs to be valuable and manageable in the daily API work.

Three hot topics out of the long list of options how to obtain and implement Process Knowledge in your company are selected and
will be considered and explained during the Pre-Conference Session. Besides explaining the requirements of the guidelines of e.g.
the ICH Q7 and ICH Q12 guideline for the respective themes, the speakers will share their approaches, experiences and best practices
on these API related quality and regulatory topics.

Target Group

This Pre-Conference Session is designed for all persons involved in the manufacture of APIs especially for persons from production,
quality control, quality assurance, technical and regulatory affairs departments. We are also addressing interested parties from the
pharmaceutical industry and GMP inspectorates.


Pre-Conference Session to the 27th APIC/CEFIC Global GMP & Regulatory API Conference - in Vienna or online

Seminar Programme as PDF

Control Strategy from a Quality perspective
  • Sound science & risk management all along the life cycle
  • Quality Trends
  • Elements of a control strategy
  • QRM as integral part of quality by design
  • Areas of controls (hierarchy and practical examples)
  • Impact on cost of quality

Control Strategy from a Regulatory perspective
  • The control strategy in the regulatory files
  • A complete Story
  • What to share with the customers

Changes from a Quality perspective
  • Different changes during product life cycle
  • Scope and importance of a change Control
  • General change control requirements
  • Detailed change control requirements for specific systems (i.e. materials, process, equipment, utilities, specs & methods) with practical examples
  • Implementation requirements

Changes from a Regulatory perspective
  • Change procedures in different regions
  • Supply chain issues related to changes
  • The impact of ICH Q12

Reprocessing and rework: options and obligations
  • Definitions
  • ICH Q7 section 14.2 and ICH Q7 Q&A section 14
  • Q&A’s on practical real-life examples

Regular Fee*: € 1090,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

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Testimonials about our courses and conferences

“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



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023