Best Practice Standards for the Development, Manufacture and Distribution of Medicines

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...

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Duration
40 hours
Course Price
£POA

Learning Objectives

  • ICH Q11 Guidelines on Development and Manufacture of Drug substances
  • EDQM active ingredient supplier Audits and update on the CEP procedure for API suitability for use
  • To be able to apply the principals of Risk based assessment that is fundamental to the manufacture of any pharmaceutical dosage forms.
  • To review regulatory Guidance on Process validation and consider the implications of the GAMP requirements for Product and Process Validation.
  • To prepare for a regulatory authority Inspection and to consider all aspects of the inspection process.
  • The management of Quality in the development and manufacture of Medicines.

Course Description

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.

Certification Requirements

To qualify for a certificate of competence the following courses must also be satisfactorily completed.

Pharmaceutical Regulatory Overview

Duration: TBC

Drug Development Process

Duration: TBC

Introduction to Good Manufacturing Practice

Duration: TBC

GMP for Biopharmaceuticals and Biosimilars

Duration: TBC

Good Laboratory Practice

Duration: TBC

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