About this Course

Post Diploma Certificate in Pharmaceutical Quality Systems Module Synopsis cGMP Compliance The module will provide an overview of the GXP regulatory standards and requirements in pharmaceutical industry and starting with the drug development process to the production of the finished product. GMPs and the Quality Management Systems covering organization and personal, equipment and facilities, contamination control, documentation management, packaging and labeling and API and biologics manufacturing will be covered. Validation The module will cover the principles and practices of Validation providing an introduction to organization of the validation process. Topics will include validation of critical units, cleaning and sterilization, methods, computer systems and processes. The validation of biopharmaceutical processes will also be covered. QA and Documentation The module will cover documentation and its role in Quality Assurance in pharmaceutical manufacturing. Documentation requirements under GMP, ISO Quality Management System and ICH guidelines will be compared. International quality and regulatory requirements including those of the HSA will be compared. The module will cover documentation requirements for quality events including customer complaints, Out of Specifications, Deviation Investigations, Root Cause Analysis and Corrective Action Preventive Action. The topic of documentation requirements for Qualification and Validation will cover Change Control, IQ, OQ and PQ, method validation for incoming materials, process control and finished product quality. The components of the QA Documentation System and Good Documentation Practice will be covered. The module will also cover Quality Audits, regulatory inspections and interpreting and responding to FDA 483 Warning Letters. QC Analytics The module will focus on QC issues in Biopharmaceutical and related manufacturing practices which include an overview of QC regulatory requirements and an overview of the methods used in determine the quality of Biopharmaceuticals. Topics include total protein analyses, DNA and protein electrophoresis, IEF, 2D gel electrophoresis, capillary electrophoresis, HPLC methods for protein analyses, bioactivity assays, determination of viral and mycoplasma contamination.

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