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Practical Process Validations - Pack of Two Courses
This Validation training will explain the intent and importance of process validation.
Description
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.
Module 1:
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.
Module 2:
Part 2 in this two-part series will detail the key qualification steps in process validation, the use of statistical methodology for sampling plans and acceptance criteria, how to handle deviations, elements of a good validation summary report, change controls and revalidation. Sustainability and maintaining a validated state will also be discussed.
- Process validation Planning and Prerequisites - recap from Part 1.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Statistical tools, techniques and quality metrics.
- Sampling Plans.
- Process Control.
- Deviations and how to handle them.
- Validation summary reports.
- Change Controls.
- Revalidation.
- Validation Life Cycle.
Who will benefit:
- 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
Instructor Profile:
Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.
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