Process Validation for Drugs and Biologics - NUSAGE - National ...

PROFESSIONAL TRAINING
Process Validation for Drugs and Biologics
Objective
The objective of this course is to outline the importance and principles of process
validation in the pharmaceutical and biopharmaceutical industry. Participants of this
course will gain understanding of the FDA perspective of “Process Validation Life-
Cycle”, and will be able to develop validation protocols and reports that meet current
FDA, WHO, PIC/S and EU regulations.
Synopsis
This course provides practical guidance for pharmaceutical, biologic and
biopharmaceutical manufacturing professionals on compliance with the requirements
of process validation. This course stresses the importance of quality, where quality
must be designed into the process/product to reduce the risk of non-conformances
during/after manufacturing.
Instructor
Dr Rick Ng holds degrees in BSc (Honours), PhD
and MBA. He has worked in senior positions in
Clinical, Quality, Regulatory Affairs and Business
Development in the biotech and pharmaceutical
industry in Australia and Singapore for more
than 20 years. Currently Rick provides
consulting and training services in GCP, GMP,
Quality, Regulatory and Validation. Rick is the
author of one of the best selling
medicine/pharmacology books, Drugs: From
Discovery to Approval, which is a recommended
text in a number of universities/colleges.
Outline
• Fundamentals of Process Validation
o Validation terminology
o Process validation program
o Master Validation Plan
• Validation Life Cycle
o Process design
o Design qualification
o Continued process verification
• Validation Protocols
o Developing process validation protocols for pharmaceutical and
biopharmaceutical processes
o Solid dosage manufacturing
o Aseptic Filling Process
• The Future of Process Validation
o Process Analytical Technology (PAT)
o ICH Q8 and Q9 Guidelines
o Quality Systems Approach to Pharmaceutical cGMPs – FDA and ICH
Learning Outcomes
Upon completion of this course the attendees will be able to:
• Gain an understanding of the principles of process validation
• Gain an understanding of current regulatory perspectives from the US FDA, EU, and
PIC/S
• Gain an understanding of the “process validation lifecyle” concept, including
planning, developing protocols, executing, and maintaining.
• Learn to apply the “process validation lifecycle” concept in planning, executing, and
maintaining a validation program that is compliant to regulatory expectations.
• Gain an understanding of evolutions in process validation concepts, such as how
process analytical technology (PAT) can simplify process validation, the Quality by
Design (QbD) concept that harmonizes emphasis on designing quality into the
process and product, and more.
• Learn how the new process validation concepts such as PAT and QbD can be applied
to your process by discussion, as well as pros and cons
Who Should Attend & What Participants Will Benefit From
This course is intended for persons who are directly involved in the development and
execution of process validation in a manufacturing setting, Suitable for personnel from
R&D, QA, QC, Validation, and Technical Services.