Practical Process Validation Part 1 - Validation Planning, Prerequisites and Best Practices

This Validation training will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

Part 1 in this two-part series will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation including risk management. Effective validation planning, Validation Master Plans and best practices in process validation will also be discussed.

Areas Covered in the seminar:

• Process Validation and the FDA Regulations (21 CFR Parts 211 and 21 CFR Parts 820).
• Key terminology.
• Why validate? Process Validation intent and benefits.
• Verification and Validation.
• Types of Validation.
• Validation Planning and Validation Master Plans.
• Schedules, roles, responsibilities, and reviews.
• Process Validation and Design Control.
• Product specifications and acceptance criteria.
• Risk analysis.
• Protocols and documentation.
• Process Validation - best practices.

Who Will Benefit:

This Webinar will be of value to all those involved in product development, process development, quality control, quality assurance, and manufacturing.

• Research and Development personnel
• Product development personnel
• Process engineers
• Manufacturing managers and engineers
• Validation Managers and Engineers
• QA/QC managers and personnel
• Regulatory personnel
• Project managers