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.
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.
• 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.