• Understand the importance and underlying principles of process validation
• Understand the new/revised concepts as stated by the FDA’s new Draft Guideline on Process Validation and its impact on how process validation activities are carried out
• Understand the new FDA perspective of a “Process Validation Life-Cycle” that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness)
• Be able to set up process validation protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
• Prepare and defend your own process validation approach/ program and avoid costly delays and rejections by regulatory agencies

Course Description

Process validation is not a curse invented by regulators and pushed onto a company by QA staff.  Instead, it is a legal requirement in the pharmaceutical industry.  The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing.
 
This course provides practical guidance on compliance with the requirements of process validation that lead to risk-based, reasonable and supportable informed decisions.  Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.
 
The course includes process validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes. This includes the manufacturing of the API and the finished drug products.

View Course Agenda

Past Participant's Comments

“Great instructor, excellently presented, great flow and material is well organized."
Jessica B., Scientist, Wyeth

“After this course I have a much clearer and better picture of how to plan and execute the process validation for my future programs.” 
Shuguang Z., Director, Chemical Development, Ascenta Therapeutics

“I really enjoyed this course and the course director did a great job explaining the validation processes in terms that I could understand.  I would absolutely recommend this course to others.” 
Renee P., Validation Specialist, Hollister-Stier

“The Course Director was extremely knowledgeable and very good at involving everyone.  She not only presented the material, but also tested our understanding which was a fantastic method to start lively discussions and applicable question/answer sessions.” 
Jo G., Validation Engineer, Rockwell Automation

“Exercises were great.  They force you to apply what you're learning and exchange ideas with other professionals.!” 
Validation Engineer, Amgen

“I enjoyed this course, I feel more confident in the validation program we have in my company, even though we’re a medical device manufacturer.  We do not manufacture drugs or biologics but we do use drugs with our devices.”  
Terese O., QA, Abbott Vascular

“I really enjoyed this course!  Even though I have participated on process validation teams in the past, there was still a lot to learn.” 
Julie W., Director of Quality Assurance