Course Description

This training is intended to help you better understand and get familiar with best practices for Process Validation applicable for the highly regulated biological/pharmaceutical industry. This course is further intended to discuss the life cycle of the Process Validation system. You will learn when a process should be validated, the basic components of a Process Validation  and how to write protocols and reports.

Who should attend ? 

This training was developed for professionals engaged within a variety of processing industries, including Pharmaceuticals, Biopharmaceuticals, Biotechnologies, Cosmetics, Chemical and Specialty Chemicals.

The tools in this course will be very beneficial for

R&D Scientists.

Quality Control Professionals.

Quality Assurance 

Production Professionals

and anyone whose’ s job requires product and manufacturing processes design, optimization, troubleshooting, etc.

Course Topics:

•Life Cycle Approach of Process Validation

•Phase 1 : Process Design - Case Study

•Phase 2 : Process Performance Qualification (PPQ)

•Phase 3 : Continued Process Verification (CPV)

•Workshop : Creation of protocols for solid , Liquid, and Semi_ Solid products.

Number of Sessions :

  4 sessions

Instructor:

SPEAKER

 Mohamed El- Khatieb 

                    Head Of Quality Assurance

14+ years of quality system experience -Speaker at PHARMACONEX Conference  - ASQ Certified Six Sigma Black Belt