Good Manufacturing Practices in API Production: How to Implement ICHQ7
Good Manufacturing Practices in API Production: How to Implement ICHQ7

Course Description

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.
  • 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
  • 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

Good Manufacturing Practices in API Production: How to Implement ICHQ7

TBC, Live Online Training
€1.850,00
Francois (Swa) Vandeweyer

Swa joined Janssen Pharmaceutical in 1981 and had increasing responsibilities within the organisation, mainly in the Quality Control Unit. From 2005 he was Senior Manager GMP Compliance Chemical Operations in Belgium and from 2009 he was appointed as Director Global Compliance of EMEA and Asia Pacific.

Training dates will be announced soon. In meantime, feel free to request an agenda.

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Course Description

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.
  • 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
  • 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

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Good Manufacturing Practices in API Production: How to Implement ICHQ7

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