RAPS pre-approved webinar on "Process Validation - current industry practices and FDA Guidance Document Review" from GlobalCompliancePanel
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Process Validation -current industry practices and FDA Guidance Document Review" on October 2.
- Washington, DC-MD-VA-WV (1888PressRelease) October 02, 2012 - This webinar talks about current industry practices and FDA Guidance Document Review for Process Validation.
PV is a critical matter for regulatory and compliance professionals. Being a mandatory and non-negotiable requirement for the FDA; PV is needed to demonstrate the consistency of pharmaceutical processes. Writing and executing a PV document can often be complicated because it involves a validation protocol that has to explore and take into account variation -both natural and induced -that has gone into the process. It has to then demonstrate that the process is good enough to consistently and reproducibly produce a quality product.
Since there is no single standard or approach to PV in the pharmaceutical industry; there is scope for confusion and complexity. Today's pharma and biotech fields are quite complicated, making PV all the more difficult. This makesan important component of a PV -that of deciding what can be varied and how much -harder to fulfill.
This session seeks to give participants familiarity with the basics of PV and the current industry practices that go into it. It will review the recent draft FDA Guidance Document on Process Validation. It will also present case studies in which practical examples of good examples of PV protocols will be shown.
When:October 2, 10:00 AM PDT | 01:00 PM EDT
By whom:John R. Godshalk, MSE, MBA, is a Senior Consultant at the Biologics Consulting Group.
John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Divisionof Manufacturing and Product Quality at the Center for Biologics Evaluation and Research(CBER), Food and Drug Administration (FDA) for over three. Prior to joining FDA he worked asa management consultant after obtaining his MBA.
John has experience with products that include drugs,drug/device combination products, viral and bacterial vaccines, recombinant therapeutic andfractionation products, in vitro diagnostic test kits, and 510K medical devices. His inspectionexperience includes leading inspections of active pharmaceutical ingredient manufacturers,aseptic filling and finishing facilities, and contract manufacturers.
John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. He currently works to assist clients inthe areas of cGMP, regulatoryaffairs and management consulting.
For whom:
The webinar will benefit
o Director of Quality
o Manager of Quality
o Validation Manager
o Validation Director
o Director/Manager of Regulatory Compliance
Duration:60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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