Change Control in the GMP Environment (EU Edition)
Days
Hours
Minutes
Seconds
This course includes:
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
Course outline
Change control lies at the heart of GMP compliance. Whether it’s manufacturing, testing, or regulatory submissions, every process hinges on managing changes efficiently and effectively. This course dives into the latest requirements, showing you how to align with current standards while anticipating future regulatory expectations. Imagine confidently addressing questions about interfaces, tracking changes, and ensuring every adjustment complies with EU regulations. Through interactive sessions and practical insights, this masterclass transforms complex concepts into actionable strategies.
What You’ll Gain
-
Navigate Regulatory Frameworks with Confidence
Gain a comprehensive understanding of ICH Q9 and ICH Q12 guidelines, ensuring your processes meet the highest standards of compliance. -
Implement Risk-Based Change Control
Learn to categorize changes, manage deviations, and integrate CAPA systems effectively to streamline your operations. -
Manage the Consequences of Changes
Discover how to address revalidation needs, update manufacturing descriptions, and manage stability studies without disrupting workflows. -
Master Variations and Regulatory Compliance
Understand how to document changes in regulatory dossiers, implement lifecycle concepts, and manage responsibilities between marketing authorization holders and contract manufacturers.
Why This Masterclass?
- Learn from a Renowned Industry Leader Prof. Dr. Markus Veit brings over 25 years of experience in pharmaceutical development and regulatory affairs. His ability to distill complex regulations into practical insights makes him an exceptional trainer for this masterclass.
-
Focused, Practical Training
From categorization of changes to the intricacies of regulatory compliance, every module is designed to equip you with tools you can use immediately. - Interactive and Comprehensive Sessions Through case studies, Q&A discussions, and hands-on activities, you’ll leave with a deep understanding of change control processes and their implications.
Who Should Attend?
- Regulatory Affairs
- Manufacturing
- Quality Control and Quality Management
- Qualified Persons (QPs)
- Departments managing outsourcing and compliance
Agenda Highlights
Day 1
- Regulatory environment and the role of change control.
- Interfaces needed for seamless change implementation.
- Delimitation of responsibilities in change vs. deviation management.
Day 2
- Consequences of changes: revalidation, stability studies, and options for biowaivers.
- Lifecycle concepts for analytical test methods under ICH Q14.
- Documentation strategies for both GMP compliance and regulatory dossiers.
About Trainer
Prof. Dr. Markus Veit is a pharmacist with special expertise in pharmaceutical analysis and validation. As the managing director of ALPHA-TOPICS GmbH, he has spent over two decades leading projects in pharmaceutical development, regulatory affairs, and GMP compliance.
Key credentials include:
- Membership in the German pharmacopeial expert committee at BfArM.
- Extensive experience in designing training programs for the pharmaceutical and medical device industries.
- A proven track record of guiding professionals through regulatory complexities with clarity andprecision.
Access for 2 participants
Online Participation
1,590$
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Certificate of completion and LinkedIn certificate
-
Access for 2 participants
Online Participation with Recording
1,989$
- Interactive Masterclass
- access for 2 participants
- Dedicated Conference Manager
- Case Studies / Q&A sessions
- Access to Training Materials. (PPT/PDF)
- Recording access
- Certificate of completion and LinkedIn certificate
Request Agenda
Companies Represented By Our Participants
Proud Stories
★★★★★
Marsha Miller
Pragmatic approaches and clarification on when statistics is useful and when not. Perfect guidance through the official guidances out there and pointing out where they are sometimes contradictory and therefore confusing during application in daily work. Very honorable teacher and very good at making complex things understandable. As the head is spinning after such intense training, the hand-outs and workshop documentation given will help in having the learned content re-called
★★★★★
Michael Durschlag
James provided a comprehensive, detailed, and complete view of Annex 1 updates, tied it to QRM and to PICS guidance. He delivered the material in an easy-to-understand format, and we did not experience any problems with the streaming. The slide material provided will be very useful as a reference.
★★★★★
Nancy Musik
This was a very in-depth training, and I especially appreciated the real-life examples or possible solutions and real industry examples and mitigation approaches. Trainer definitely a SME on this subject and was able to provide lots of information and background details to explain Annex 1 intentions.
★★★★★
Vyara Kuneva
The training offered a large scope of relevant information, presented in an understandable and interesting way. The hands-up approach, supported by examples and simulations makes the content easy to understand and remember. The lecturer was excellent, and the course was very well organized.
★★★★★
Walter Drexler
I have never seen such an extensive session on statistics for practitioners on all these burning topics provided. It basically covers all of them we also discuss in our company. A great spectrum of topics covered.
★★★★★
Seth Byers
Well organized presentation, very knowledgeable presenter, great atmosphere
★★★★★
Hassan Abdu Al Asmary
Touched my needs, Mr. James is a wonderful lecturer who made it easy and clear.
★★★★★
Gabriela Saucedo
The facilitator and expert, the documents shared, the excellent facilitation skills of James and being engaged in the session.
★★★★★
Vassia Papakonstantinou
I really liked the flow of the presentation, and the way modules were explained using the appropriate ICH references
★★★★★
Nereus Jethro Abad
I enjoyed the class and found it informative, engaging and filled with valuable insights.
What you'll get?
-
Collaborative environment that
encourages interaction - Case studies and Q&A sessions
- Training materials
-
Tools and techniques to apply
immediately in your role - Recording access
- Certificate of completion
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