Contamination Control by Design, applied to the manufacturing of Sterile Medicinal and Advanced Therapeutics (C>) product.
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
Understanding Contamination Control Strategy (CCS) and regulatory compliance. Airborne & surface contamination control techniques. Facility, process, and equipment design for contamination prevention. Advanced environmental monitoring & risk management
Key Takeaways
- A clear understanding of Annex 1 & PIC/S contamination control requirements
- Practical knowledge on implementing QbD & QRM principles
- Strategies for cleanroom management, environmental monitoring, and aseptic processing
- Insights into airborne and surface contamination control using advanced technologies
- Access to real-world case studies and expert insights
Who Should Attend?
- QA & QC professionals involved in GMP compliance
- Regulatory affairs specialists handling Annex 1 implementation
- Manufacturing & production teams in sterile pharmaceutical environments
- Validation & engineering teams designing cleanrooms and processes
- CMC assessors and consultants looking to enhance contamination control strategies
- R&D and process development specialists working in aseptic manufacturing
Agenda Highlights
Day 1: Laying the Foundation for Contamination Control
- Understanding CCS and its role in Annex 1 compliance
- Applying QbD & QRM principles in contamination prevention
- Designing effective environmental monitoring programs
Day 2: Practical Approaches to Contamination Control
- Managing surface contamination transfer and material handling
- Implementing cleanroom best practices and barrier technologies (Isolators, RABS)
- Assessing airborne contamination risks using advanced techniques
Day 3: Quality, Compliance & Lifecycle Management
- Developing a cross-contamination control strategy for sterile manufacturing
- Exploring containment strategies for high-risk products (e.g., viral vectors, ATMPs)
- Reviewing real-world case studies on contamination control and compliance failures
About Trainer
James, as ex-chairman (for 10 years) and honorary member of the PHSS:
Pharmaceutical and Healthcare Science Society, has followed Annex 1 revision to
publication with a role played in the targeted revision process. The PHSS was
appointed by the European Commission (EC) as one of the twelve (12) appointed
commenting platforms in the Targeted Consultation phase, and James was Co-lead in
commenting issued to the EC/Annex 1 Inspectors Working Group (IWG) via the PHSS
platform. James is a co-lead (together with Ex-MHRA Senior GMP Inspector) of the
PHSS Aseptic Processing and Annex 1 Focus Group and Contamination Control
Strategy (CCS) Guidance initiative. James has completed joint Workshops covering
CMC (Chemistry Manufacturing Controls) and CGMP with an ex-regulatory CMC
Assessor. In addition, James is currently the Head of GMP Compliance for Franz Ziel
GmbH, the largest Barrier Technology (Isolator and RABS) and Cleanroom Technology
manufacturer in Germany.
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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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