The new “Guidance for Industry Process Validation: General Principles and Practices” was published as a draft and came into operation in January 2011. That is now FDA’s “current thinking”. Chapter 1 of the EU GMP Guide gives hints for more emphasizes on process capabilities and varieties within process validation also in Europe. EMA’s Process Validation Guidance and the revised Annex 15 of Eudralex GMP guidance volume which came into force on 1 October 2015 takes a life cycle approach to process validation. This course gives you a complete understanding about Risk based validation approach and Stage I; Stage II and Stage III requirements, how to execute and document the same as per USFDA; EMA; EDQM; WHO; PIC(s) and ROW regulatory requirements.
Seminar Agenda:
- Process Validation Life Cycle
- Changes to the Process Validation Concept
- Principles of process validation
- Regulatory requirements of Process validation
- Guidance requirements USFDA; EU Annex 15 and EMA process validation guideline
- Conduct of process validation
- Discussion about PV Requirements
- Protocol design
- Risk based Selection of CQA and CPP
- Process validation report contents
- Process validation summary report – Process Knowledge and Process Understanding
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Validation Departments
- Compliance Departments
- Manufacturers of API’s / Formulations
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