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global compliance panel, Online Training Webinars
2011-09-21
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? How to minimize scope creep? How to conclude a project "on time" and "within budget"? How to gain management support for the Milestones, Tasks, and Timelines? Use the Plan as a powerful tool with FDA auditors. Use variations on these tools for any project, from the smallest to major company projects. Growing high-profile field problems indicate that much project management is poor or non-existent. Buy up-front time for proper project planning. These techniques are not rocket-science, but require the implementation of formal methods with documented and defensible rationale. Use these tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan".
Areas Covered in the Session:- 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
Who Will Benefit:- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants
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Organized by:
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global compliance panel |
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Invited Speakers:
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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 peer-reviewed 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 FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
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Deadline for Abstracts:
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2011-09-21
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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