Pharma & Biotech

Good Manufacturing Practices in API Production: How to Implement ICHQ7

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

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

TRAINER

Francois (Swa) Vandeweyer

Company Owner, VDWcGMP Consultancy gvc, Belgium

Francois (Swa) Vandeweyer is the Company Owner of VDWcGMP Consultancy gvc based in Belgium. 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. Swa retired from J&J in May 2019 and formed his own consultancy. He is a member of APIC, was the Vice Chair of the APIC Quality Working Group involved in multiple GMP Compliance documents like ICH Q7 How to do, cleaning validation, supply chain integrity and many more. We are live on webchat!

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