Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 14th Apr'24 to 24th Apr'24
Process Validation - Overview Of Why And How
- What is process validation
- Why is process validation necessary
- Process validation guidelines
- How to determine if a process requires validation
- What processes should be validated
- Process validation outline
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- Process monitoring
Overview of the webinar
This webinar will provide an understanding of FDA and ISO 13485 requirements for process validation and how to implement them. The session will cover the basics of this important topic for those who are new to the quality or new to process validation. It will also:
- Cover the requirements for process validation from FDA cGMP and ISO 13485
- Discuss when process validation and revalidation are necessary or desirable
- Provide an outline of equipment qualification
- Provide an overview of what is required for process validation
Who should attend?
- Quality Engineers
- Manufacturing Engineers
- Internal Auditors
- Compliance Specialist
- Others in Quality
- Quality Managers new to medical devices or process validation
- Operations/Manufacturing Managers new to medical devices or process validation
- Medical device consultants new to process validation
- Engineering Managers
- Auditors
Why should you attend?
Process validation is a requirement but knowing when to validate or revalidate a process is essential. If you do not validate you risk enforcement actions such as fines or recalls, but too much validation is costly in both time and money. The Learning Objectives are:
- Learn why process validation is necessary
- Understand what process validation is
- Learn about process validation guidelines
- Understand when to validate processes and what processes to validate
- Understand how to do process validation
Faculty - Ms.Betty Lane
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium-sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements while having a cost-effective Quality Management System. Her background in digital systems engineering enables her to facilitate implementation of design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty’s training experience includes over 25 years of training on all aspects of FDA Quality System Regulation (cGMP) and ISO 13485, the ISO standard for Medical Device Quality Management Systems. She had done training in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.