Process Validation Requirements & Compliance Strategies
Instructor:
Jose Mora
Product ID: 700162
Training Level: Intermediate
- Duration: 60 Min
Why Should You Attend:
When applied correctly, process validation can result in higher process dependability, higher yields, and lower operating costs.
Areas Covered in the Webinar:
- Global Harmonization Task Force requirements (includes FDA and ISO)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Design Qualification
- Facilities and utilities
- Strategies for achieving a robust and reliable process.
- Typical process validation protocols.
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
- Research & Development
- Quality Engineers and Auditors
- Manufacturing Engineers
- Quality Assurance & Quality Control Teams
- Operations Teams
- Document Control
- Device Development Teams
- Personnel involved in Verification and Validation planning, execution and documentation for devices
From Pharmaceutical, Medical Devices, Biotechnology, Clinical Trial and Clinical Research Companies
Instructor Profile:
Jose Mora
Principal Consultant, Atzari Enterprises
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.
Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.
Topic Background:
Following the implementation of the results of a Human Factors/Usability study, a validation of the safety and effectiveness of the use of the device must be conducted.
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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).
