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QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1)

Name: QA & Documentation - Part of Post Diploma Certificate in Pharmaceutical Quality Systems (ADMP1)
Price: 1647.00 SGD
Rating: 5 (3 reviews)

Training Provider: Ngee Ann Polytechnic

Course Reference: TGS-2023020544

S$1,647

About This Course

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.

What You'll Learn

In this module, students will learn the essential role of documentation in Quality Assurance for pharmaceutical manufacturing. They’ll explore documentation requirements under GMP, ISO, and ICH guidelines, as well as international regulations, including those from the HSA. The module covers handling quality events like customer complaints, deviations, and CAPA, alongside qualification and validation processes (IQ, OQ, PQ). Additionally, students will understand the QA Documentation System, Good Documentation Practices, and how to navigate Quality Audits, regulatory inspections, and FDA 483 Warning Letters.

Entry Requirements

• A Diploma / Degree in technical disciplines such as Science, Engineering or Information Technology, or
• A Diploma or Degree in a non-engineering / non-technology disciplines AND a Credit or minimum grade of C6 in GCE "O" level Science Subject.