GMP06001 2019 GMP 1 Quality Assurance

Demonstrate a basic grounding in the fundamentals of GMP, its regulatory basis and the critical role these GMP practices play in ensuring that pharmaceutical products and medical devices are consistently safe and effective, and are produced to high quality standard.

Describe the roles of QA and QC within a Quality Management system and their location within the process flow. Communicate examples of QA/QC responsibilities relevant to various processes.

Describe the roles of all personnel, training, engineering, maintenance, production and contractors within a GMP organisation.

Explain and illustrate the concepts of proper documentation utilized in a GMP environment and its function in traceability investigations and formal contracts.

Participate in the use of the tools and methodologies that provide an approach for developing corrective and preventive actions that address and limit manufacturing failures.

Describe key principles that ensure the validity of all data generated within a GMP environment.

Lectures are delivered online and recorded and are supported by PDF lecture notes.

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Introduction to GMP/ History of GMP

Eudralex/ FDA CFR'S/ ICH/ Quality Management

Personnel / Premises & Equipment/ Sterile Products

Documentation 

Quality Assurance and Quality Control 

CAPA and means of preventing cross contamination.

Auditing