In partnership with NUS

Academy of GxP Excellence since 2009

Objective

To have an understanding of current QA topics in post-market maintenance of pharmaceutical products, and which are of key importance for QA management and personnel to consider.

Description

 

This course provides an understanding of the principles and practice of pharmaceutical quality assurance and control and of specific topics, which have become important because of regulatory interest or recent technological achievements.

 

This course provides: an understanding of the basic principles and practice of the QA function in a commercial manufacturing environment, covering their role during product design, production, storage and distribution, with the role during production being addressed in particular detail, consisting of reviews, first of broad current quality issues including major regulatory agency’s activities, and then the QA aspects of a number of specific issues including: handling of laboratory controls, validation (equipment, processes, computers, cleaning and test methods), label and labeling, water systems, change control, electronic records and signatures, deviations and discrepancies, (including OOSs), regulatory agency inspections, internal and supplier audits, vendor and contract supplier qualification, annual product reviews, and training.  The QA aspects of stability program operation and also documentation are presented as well.

 

Course Outline

  • Quality Function

  • QA’s Role in Production

  • Laboratory Controls

  • Label and Labeling Control

  • QA Aspects of Water

  • Change Control

  • Deviation/Discrepancy Handling

  • Electronic Records and Signatures

  • Regulatory Inspections and Their Impact on QA

  • Internal and Supplier Audits

  • Corrective Action and Preventive Action (CAPA) program

  • Training Programs and Their Impact on QA

  • Vendors and Contract Suppliers

  • Annual Product Reviews

  • QA Aspects of Stability Programs

  • QA Aspects of Documentation

 

Learning Outcome

 

Upon completion of this course the attendees will be able to:​​

  1. Understand the concepts and methods in designing clinical trials

  2. Understand the Quality Function, as well as the role of QA and QC units in manufacturing / production

  3. Understand essential QA programs, such as change control, deviation handling, internal and supplier audits, CAPA

  4. Understand the responsibility of vendors and contract suppliers, and QA’s role in managing these relationships

  5. Understand stability programs

  6. Understand documentation practices

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