Latest guidance from FDA: Process Validation Requirements & Compliance Strategies – 2018 Webinar

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By José Mora who is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems"

In this webinar speaker will explain Strategies for achieving a robust and reliable process, Process validation is considered as the first step in process development for manufacturing biopharmaceuticals, This webinar will discuss the latest guidance from FDA regarding process validation, At the end of the webinar, attendees will be able to evaluate validation requirements for any given process.

Description

This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

Why should you Attend: 

When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses. 

Areas Covered

•       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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

José Mora

José 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.

José 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. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis? first PTA (percutaneous transluminal angioplasty) catheter.

His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as ?tops? by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core

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