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Basics - GMP for APIs (ICH Q7 Compliance)

	Content Day 1
08.00 – 08.30	Welcome and Introduction
08.30 – 10.00	Regulatory Requirements for the Manufacturing of the Active Pharmaceutical Ingredients Structure of the Regulations Europe USA Harmonisation
10.00 – 10.15	Break
10.15 – 12.15	The Quality Management System Regulatory Requirements FDA New View on QA-System Maintenance of a QA-System Main Points of a QA System Responsibility of the management Change OOS Deviation Complaints Training Communication with the Contractor
12.15 – 13.15	Lunch
13.15 – 14.30	Risk Management, ICH Q 9 Methods, Content of ICH Q 9 Performance Documentation Input on QA-System DIN EN ISO 14971
14.30 – 16.30	Qualification/Validation Regulatory Requirements Qualification of Equipment Documentation of Qualification Retrospective Qualification Requalification Cleaning Validation Validation of Processes Documentation of Validation Retrospective Validation Revalidation
15.30 – 15.45	Break (in between)
16.00 – 17.30	Quality Control Regulatory Requirements Duties of QA based on GMP-Guideline Performance of Testing QC/QA versus Qualified Person Validation of Analytical Methods Stability / Retest
17.30 – 18.00	Final Discussion

	Content Day 2
08.00 – 08.30	Remarks, Questions; Proposals
08.30 – 09.30	Facility and Material Management Qualification of Suppliers Supervision of Suppliers Maintenance of Equipment Internal External Control of Incoming Materials Storage
10.30 – 10.45	Break
10.45 – 12.45	Manufacturing of the API Requirements for Manufacturing Starting Materials In Process Controls PAT (Process Analytical Technology) Mixing up of Different Batches Reprocessing Rework
12.45 – 13.45	Lunch
13.45 – 14.45	GMP in Research and Development Requirements for a Quality Management System Implementing of a Quality Management System Documentation CTD DMF
14.45 - 16.00	Documentation Regulatory Requirements Documentation of the QA System Documentation in Production Quality Control Engineering Quality Unit Annual Product Review
15.15 – 15.30	Break (in between)
16.00 – 17.15	Auditing and Self- Inspection Regulatory Requirements Auditprogram Auditplan Performance of Auditing Supervision of Contract Manufacturer Supervision of Manufacturer for Starting Materials Nuts and Bolts of an Audit
17.15 – 17.45	Discussion