Rarely does the manufacturing process after changes remain as originally once described for approval. Change control systems deal with planned, foreseeable changes and are one of the most important components of a pharmaceutical quality management system. EU GMP Guide Annex 15 (Qualification and Validation) requires a written procedure to document the changes, and related actions for implementation of intended changes to products and processes. The live online seminar from Concept Heidelberg provides the full picture of state-of-the-art change control management.
Dr. Martin Melzer, Principal Consultant and GMP expert at gempex, will be called in as a specialist expert for this seminar on March 15/16, 2022, and will provide the necessary GMP know-how on topics of "Definition and categorization of approval-relevant changes" and "Planning of approval-relevant changes and life cycle management". If changes in the manufacturing process of active ingredients or finished products are applied for, the relevance of the given change is first classified and accompanied by a risk analysis. Questions often arise in this process such as: Which changes actually need to be reported to the local authority? Who needs to be informed about the changes? Is there a need for re-qualification? Is the marketing authorization affected?
The live event offers the following learning content and subsequently enables participants to understand and apply all essential aspects of change control:
Regulatory environment
- Legal requirements
- EU rules
- Notification requirements
- EU Variations Regulations 1234/2008
- ICH Q12 Life Cycle Management
Change management in the company
- Systematics
- Documentation
- Risk analysis
- Project planning
- Effectiveness check
Technical aspects
- Processing of technical changes
- Evaluation of GMP relevance
Supporting quality management for change control systems
- Resource management
- Information management
- Document management
- Communication management
The contents of the training will be applied in case studies at the end of each seminar day and all questions will be answered in a detailed Q&A session. For more information on the event and the speakers, please see the program here (German language).
If you have any questions about Change Management and GMP Compliance, Dr. Martin Melzer will be happy to answer them personally. Please contact him via: info@gempex.com