Managing Outsourced Manufacturing: FDA Requirements and Collaboration Tools that Streamline Compliance
Webcast
Recorded on:
12/12/2006 2:00 pm Eastern
Description:
Featuring Martin Browning, one of the leading authorities on FDA requirements and their effects on life sciences companies outsourcing any part of their operations. Mr. Browning has 22 years with the FDA as a local, national and international expert investigator, and has served as special assistant to the associate commissioner for regulatory affairs and vice chair of the agency's Electronic Records and Signatures Working Group, which drafted the 21 CFR Part 11 regulations.
For pharmaceutical companies engaged in outsourced manufacturing, this webcast provides a clear understanding of FDA requirements, which is critical since outsourcing any regulated part of their operation still leaves them wholly responsible for the quality and conduct of the supplier. From a leading pharmaceutical company, audience members will also be presented with real-life examples of challenges, best practices, and tools that have enabled success in addressing issues related to managing outsource manufacturing and the data collaboration required among outsource entities.
Who Benefits from the Webcast?
This topic will be most valuable to every member of your organization who has anything to do with quality assurance, regulatory compliance, auditing, vendor selection, outsourced project management, contracting, and vendor management and monitoring, including personnel from:
Operations
Manufacturing
Purchasing
Packaging and labeling
Plant engineering
Legal counsel
What Past Audiences Have Said about Mr. Browning:
"Mr. Browning [uses] his past experience as a FDA inspector to give an accurate insight into the FDA perspective and to cite proper examples from his own experience, which helps to put some of the regulations and expectations into better context." — Quality Manager, AstraZeneca
"Martin … provided a real sense of what the FDA is looking for today with regard to management of an outsourced supplier. He was easy to follow and very clear in his explanations of the powerpoint slides." — Account Manager, Neutrogena Corporation
"Mr. Browning's experience and presentation style were very good. He had great insight into what the FDA expects for outsourcing, and he provided good guidance for companies to move forward on those expectations." — Senior Facility Auditor, Covance Laboratories, Inc.
"The presentation was comprehensive and clear. Helpful examples were given throughout. The question and answer period after the presentation raised some interesting considerations. Martin Browning's responses to the questions were thorough and easily understood. I look forward to more presentations by Mr. Browning." — Quality Assurance Representative, IMRIS, Inc.
Please complete the registration form below for this recorded webcast.
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