Certificates of the European Pharmacopeia (CEP) on the move
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
The Certificate of Suitability (CEP) procedure plays a vital role in ensuring compliance with the European Pharmacopeia. With the introduction of CEP 2.0, significant regulatory changes impact pharmaceutical active substances. This masterclass will help you navigate these evolving requirements and stay ahead in compliance.
Key Takeaways
- Understand CEP certification & regulatory expectations
- Learn how to manage nitrosamine and mutagenic impurities
- Master control strategies for active substances
- Stay updated on EMA & EDQM guidelines
- Gain insights into life cycle management for CEPs
- Get expert guidance from Prof. Dr. Markus Veit
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 professionals in API manufacturing & marketing authorization
- EU Qualified Persons (QPs) overseeing API compliance
- CMC experts handling impurity risk assessments
- Quality teams ensuring GMP & EDQM compliance
- Business professionals in pharmaceutical supply chains
Agenda Highlights
Day 1: CEP Certification & Compliance Framework
Module 1: Fundamentals of CEPs (9:00 AM - 10:30 AM)
- Role of EDQM & European Pharmacopeia
- Certification of active substances
- EDQM inspections & dossier requirements
- Application & utilization of CEPs
Module 2: Key Dossier Components (10:45 AM - 12:15 PM)
- Starting materials, process development & control strategy
- Alternative testing procedures & stability data
- Handling TSE CEPs, sterile APIs & herbal products
- Q&A & Discussions (12:30 PM - 1:00 PM)
Day 2: Impurity Management & CEP Life Cycle
Module 3: Impurity Control Strategies (9:00 AM - 11:15 AM)
- Regulatory framework for residual solvents & metal impurities
- Managing mutagenic & nitrosamine impurities
Module 4: CEP Life Cycle Management (11:30 AM - 12:15 PM)
- Audit requirements for active substance manufacturers
- Handling CEP updates, variations & responsibilities
- Final Q&A & Closing Discussions (12:30 PM - 1:00 PM)
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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