Process Validation for Drugs and Biologics
Course Director
Course Fee
$2150.00 Regular Registration
$1950.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
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Future Live Stream Sessions (click to register)
Course Description
The application of Process Validation is becoming an increasingly important activity for pharmaceutical and biotech organizations given the critical role validated processes have in ensuring product conformance. To assist industry professionals, several guidances have been developed by regulatory agencies in the last few years that define the requirements and best practices for the effective implementation of FDA process validation.
Organizations that fail to develop an effective process validation system will face significant regulatory consequences including For Cause audits by regulators, recalls or plant closure. However, the application of process validation is not limited to the manufacturer; it also extends to include suppliers. Regulations have been established which direct organizations to assess the adequacy of process validation activities at their suppliers. For example, regulators expect organizations to begin process validation activities before new equipment is installed.
This 15 hour course is continually updated to reflect current FDA & EMA regulatory requirements. It will provide participants with an understanding of the requirements of process validation from the perspective of the US FDA regarding Stages 1,2, and 3 as defined in the FDA’s 2011 Guideline on Process Validation. They will learn how and why Stage 1 (Process Development) fits and complements Stage 2 (Process Qualification) in establishing an effective process validation program. Included will be the Risk Management approach and others (e.g., Corrective and Preventive Action and Supplier Management).
Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.
Attendees are encouraged to bring examples of FDA process validation issues/concerns that they would like to reviewed and discussed during the course.
Who Should Attend
Attendance will be beneficial to personnel directly involved in process/product development, manufacturing, quality control/assurance and process validation. This includes both beginners and seasoned operational personnel who conduct process validations. Individuals in management who interact with previously mentioned staff or communicate with regulatory agency inspectors to rationalize or defend validation programs will also benefit from attending this course.
Participants should be familiar with FDA, ISO and EMEA requirements for process validation and have a good understanding of the Pharmaceutical and/or biologic Good Manufacturing Practices.
Certification Tracks
- (BDCP) Biopharmaceutical Development Certified Professional™
- (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™
- (CPVP) Certified Process Validation Professional™
- (GLPCP) Good Laboratory Practices (GLP) Certified Compliance Professional™
- (GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™
- (GRACP) Global Regulatory Affairs Compliance Professional™
- (PDCP) Pharmaceutical Development Certified Professional™
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.