Webinar on Process Verification and Validation

MessageThis Webinar is over
Date Jun 29, 2016
Time 10:00 am
Cost $150.00
Online
Overview:  
This webinar will provide valuable guidance to regulated companies in development, implementation, or refinement of their manufacturing process verification and validation programs.
It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use of existing FDA tools by a company will be discussed. What are the expected industry trends for the future as indicated by recent FDA and other guidance documents, for which companies should now prepare?

Why Should You Attend: 
The FDA expects companies to perform meaningful, results driven manufacturing process validation, now including considering life cycle issues. While the company is held fully responsible for deciding how it will conduct process validation, alternate approaches require longer and more stringent documented rationale. Growing high-profile field problems indicate that validation and change control and its effect on regulatory review activities are not yet fully utilizing the power of current FDA guidance and associated tools, which must be a part of such an analysis. A growing push by the Agency to toughen the regulatory process in the U.S. is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.

Areas Covered In the Session:
Key process validation requirements
Current expectations
Recent process validation guidance documents
Lifecycle considerations
Expectations for the future as indicated by ICH Q7 and Q8
The "Controlled Process"

Who will benefit:
Senior Management
Regulatory Affairs
Quality Assurance
Production
R&D and Engineering
All personnel tasked with process verification and validation

Speaker Profile:
John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. 

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/Process_Verification
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