This process validation training for Pharmaceutical Manufacturers will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection. Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license.
Areas Covered in the seminar:
This webinar will cover what one needs to know to set-up and execute successful process validation of a cGMP pharmaceutical manufacturing process. We will examine how integration of the following topics enables surefire process validation:- Process attributes, parameters and ranges
- Process development, process characterization and process scale-up
- Part 211 requirements
- EMEA and ICH Guidances
- Risk analysis
- Process validation within the overall cGMP validation landscape
- Integrated process validation documentation
- Validation master plans
- Process validation master plans
Who Will Benefit:
All executives, directors, managers and technical staff involved with the execution or review of process validation from the following functions:- Product, process and formulation development
- Project management
- Analytical development
- Manufacturing sciences
- Manufacturing
- Quality assurance
- Quality control
- Regulatory affairs
Course Provider
Rodney E Thompson,
