This Foundation Courses will present the control standards necessary to assure compliance with Good Manufacturing Practices and the safeguards necessary to exclude adulterated materials being used...
This Foundation Courses will present the control standards necessary to assure compliance with Good Manufacturing Practices and the safeguards necessary to exclude adulterated materials being used in the preparation of the finished product. The contents of ICH Q7 will be discussed as a general set of agreed requirements and, finally, findings from recent FDA inspections will be presented as we understand the reasons for GMPs in such a way as to provide a necessary understanding of why we do what we do.
This is a practical course focuses on the risk-based assessment of Pharmaceutical manufacture, the preparation of appropriate data required for inclusion in a new Product Drug dossier and ensuring compliance with the regulations for Good Manufacturing Practice.
The course will prepare delegates for a GMP Regulatory inspection of facilities to manufacture all common dosage forms and will provide all participants with a step–by–step guide of the regulations, practical sessions and will consider a number of case studies, there will be group discussions on all topics covered in the course.
To qualify for a certificate of competence the following courses must also be satisfactorily completed.