Practical Project Management to Meet FDA Requirements
Date & Time: Wednesday, September 21, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Price : $245.00
(for one participant)
John E Lincoln Consultant, Medical device and Regulatory affairs,
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
Why should you attend: The FDA expects companies to manage projects formally - to include regulatory requirements, design and/or change control, with consideration of all applicable standards. These tools also provide the perfect response mechanism for communication with the FDA. The EU MDD and their notified bodies are no different. How can this be done from a project's inception? How can a Project Leader or Project Manager ensure critical elements are not omitted until late in the project when disaster looms?
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Why formal Project Management The three most common tools How to compile Gantt, CPM, PERT Simple construction techniques Work breakdown Structure, Milestones, Tasks Effectiveness -- Determining and Monitoring A "New Product" Template One "Remediation Response" Template+B4
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Areas Covered in the Session:
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 peerreviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
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Who Will Benefit: l
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Senior management in Drugs, Devices, Biologics, Dietary Supplements QA
RA R&D Engineering Production Operations Consultants; others tasked with project leadership responsibilities
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