Utilization of a Lifecycle Validation Approach Via a Quality System to Reduce cost and Increase Compliance
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
James Carron, has a BS in Chemistry/ Mathematics from Missouri State University who has over 26 years of industry management experience including Validation, Quality Control, Quality Assurance, and Research and Development, and Supply Chain. His experience includes pharmaceuticals (aseptic and solid dose), medical devices, and biotech products.
Most recently spent the last six years doing the Quality oversight for Amgen SAP implementation. Currently is an independent consultant in the areas of compliance, validation, Quality assurance and Quality control as well as constructing cost containment cost control strategies.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: The great approach by the author where he does give us the information about Utilization of a Lifecycle Validation Approach Via a Quality System to Reduce cost and Increase Compliance and will detail how to implement tools that will result in a more responsive cost-efficient approach to validation activities. This approach will allow for better senior management accountability and corporate governance as well as the identification of responsible (accountable stakeholders) individuals for these validated processes.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend: The FDA in January 2011 published an updated guidance on process validation. This guidance addresses a lifecycle approach to validation that addresses validation incorporating the product lifecycle. This presentation addresses how to take advantage of the guidance to facilitate transition from R&D into a production setting.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation: Objectives of the presentation are to cover areas topics on: Incorporation of ICH Q8, Q9 and Q10 into your development processes. Where and how to incorporate into existing projects. Pilot phase Scale-up phase PPQ phase Continuous verification phase/implementation of a Continuous improvement strategy Benefits Governance oversight (Executive Accountability) Case Studies
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit:
Research and Development Project Managers Senior Management Executives Technical transfer professionals Operations Executives Supply Chain Executives Quality Assurance Executives Regulatory Compliance Associates and Managers
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works? Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896
Recorded Session - How it works? A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf format will be mailed to you Get certification of attendance.
customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com