[NP-AMP1-24] QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1)

About Course

Course Objectives

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 Preventative 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.

Course Description

QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1) is a 45 hrs module.

Course Structure

TPG course reference No.

TGS-2023020544

Entry Requirements