Process Validation for Drugs and Biologics Course | CfPIE

Are you a professional in the pharmaceutical or biotech industries who needs to update their knowledge of process validation for drugs and biologics? There are many new regulations and guidelines that are always being updated, and keeping your education up-to-date helps improve your resume and your performance at work. It also ensures that your company is working within all legally required process validation procedures. This two-day course from CfPIE, Process Validation for Drugs and Biologics, will provide you with a thorough knowledge of all the latest requirements.

What Will You Learn in Process Validation for Drugs and Biologics?

There are four main things that this course will cover:

• You will understand the updated Process Validation Life Cycle according to the FDA, which begins with the process design, and continues through the process verification.
   
• You will understand the updated process validation requirements from the EMEA, ICH, WHO, and PCI/S as well, and we’ll cover how to incorporate all the requirements from these agencies and the FDA into a single system.
   
• You will be able to create and implement a process validation program of your own design that meets all the requirements necessary.
   
• You will learn how to troubleshoot process validation issues, prove that your program meets all requirements, and avoid delays and rejections.

Important Logistics of the Program

This is a two-day course that runs from 9:00 to 5:00 both days. On both days, breakfast and lunch are included. This course is meant for anyone currently involved with process validation duties, from beginners to seasoned personnel. The course does include an overview for beginners, but also allows experienced professionals to get plenty of new and updated information, as well. The only thing participants need is a basic familiarity of FDA, EMEA, and ISO requirements for process validation, as well as a good understanding of GMP for the pharmaceutical or biologic industries.

What to Expect During the Course

With this program, you can expect both days to be packed full of information. However, the instructor does leave time for questions, and there is hands-on instruction to ensure that every student gains the knowledge they need from the course.

On day one, there will be a brief introduction to process validation for beginners, followed by a thorough explanation of how to develop and implement your own system. On the second day, the class will pick back up with executing the system, and then you’ll dive into all the legal requirements and updated guidelines. By the end of day two, you will be able to competently prepare and defend your own process validation system when presented with common issues.

This CfPIE course is open for registration. Sign up early to get a discounted course rate!