Summary
This 3-day course provides an excellent knowledge of the requirements laid down in ICH Q7 and ICH Q7 Q&A. GMP hot topics of the guideline will be explained using real life examples. Practical advices will be given on how to fulfil the requirements of ICH Q7. Key principles of risk management, quality systems, development and manufacture of APIs as they are described in ICH Q7, Q9, Q10, Q11 and the ICH Q7 Q&A Document will be discussed.
Learning Objectives
- Transfer of “What to Do” ICH Q7 requirements into “How to do” practices
- Understand at which stage of production GMP compliance is to be applied
- How to comply with GMP hot topics like process validation, re- processing/reworking, equipment qualification, change control, failure investigation etc.
- How to use a risk-based approach within the concept of supplier qualification, Data Integrity, and cleaning
- How to link material attributes and process parameters to drug substances CQAs, and creating lean quality systems
- Understand what must be prepared for a GMP inspection
- How to audit and evaluate “systems” in non-regulated environment like fine chemicals and starting materials
- Insight in special manufacturing conditions for low-bioburden API’s and High Potent API’s
Key Topics
- ICH Q7 an ICH Q7 Q&A Hot topics and requirements
- Use of risk based approaches
- Supply chain integrity
- Starting Materials
- Cleaning Validation
- Data Integrity
- ICH Q3D and nitrosamines assessments
- Low bioburden API’s and High Potent API’s
Who should attend?
This training course is designed for all persons involved in:
- The manufacture of APIs manufactured by chemical syntheses:
- Especially for persons from production
- Quality control
- Quality assurance
- Technical
- Engineers
- Regulatory affairs departments
- Qualified Persons
- Auditors
- The course also addresses interested parties from engineering companies:
- from the API
- Pharmaceutical industry
- GMP inspectorates
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Swa joined Janssen Pharmaceutical (part of Johnson & Johnson) in 1981 and until 1995 had increasing responsibilities within the organisation, mainly in the Quality Control Unit. From 1995 he joined the Quality Assurance department. In 2005 was Senior Manager GMP Compliance Chemical Operations in Belgium, on sites Geel – Olen – Beerse. In 2009 was appointed as Director Global Compliance of EMEA and Asia Pacific for Johnson & Johnson.
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