Process Validation - Overview of Why and How
Instructor:
Betty Lane
Product ID: 703520
- Duration: 60 Min
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 risk properly, you may face enforcement actions such as fines or recalls. However, too much validation is costly in both time and money.
This webinar will cover the basics of this important topic for those who are new to quality or new to process validation. It will:
- 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.
Learning Objectives:
- 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
Areas Covered in the Webinar:
- 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
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Quality Engineering
- Manufacturing engineers
- Internal auditing
- Compliance
- 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
Betty Lane
Founder and President, Be Quality Associates LLC
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, as well quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate compliance with 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 areas ISO 13485 and FDA cGMP, in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs 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 Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.
Frequently Asked Questions:
- If inline checks are being completed during production for the life of production is a process validation required?
- What is meant by process and test software?
- Can the procedure for dealing with deviations/nonconformance be specific to the protocol or detailed in another document such as the quality management system/master validation plan?
- Why is it more acceptable to have the process owner to make the requirements document?
More Training By Experts
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- Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (8 Courses)
- Implementing Robust Supply Chains
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
