Practical Process Validation Part 1 - Validation Planning, Prerequisites and Best Practices
Instructor:
Vinny Sastri
Product ID: 701123
- Duration: 90 Min
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
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.
More Training By Experts
- Design for Six Sigma in Medical Devices: Integration with the FDA Quality Systems Regulations
- Designing in Quality via Statistical Process Control
- Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer
- Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management
- What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained
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