Training Course Syllabus:

Process Validation - Current Industry Practices and FDA Guidance Document Review

Why Should you Attend

Process Validation is required by FDA and most worldwide regulatory bodies. Process Validation demonstrates consistency of pharmaceutical production processes. Process Validation requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product.


Writing and executing good process validation can be a daunting task given the complexities of today´s biotech and pharmaceutical processes. Guidance’s are helpful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and control limits are introduced and explored as tools for performing process validation.

Objectives of the Presentation:

Seminar Summary:

Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols. (see full course description)

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