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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

Location: Online

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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Instructor Profile:

Overview:

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

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.


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Practical Project Management to Meet FDA Requirements  

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Tech...

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