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ComplianceOnline, Online Event
2011-03-08
This FDA-Regulated webinar on Project Management will discuss and provide examples of most common project management tools and how to use it immediately to comply with FDA and EU MDD regulations. 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. The EU MDD and their notified bodies are no different. This Project Management for FDA-Regulated Companies 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. We will discuss one very simple approach using common Excel- or Word-type PC applications programs that can be used immediately. Three of the most common tools will be discussed. Regular use of a few simple but powerful tools will be showcased which will virtually eliminate "fire fighting" in a new project. Areas Covered in the Seminar: - Meet key requirements of the CGMPs/ISO with formal project mgmt.
- Why formal Project Management.
- The Three Most Common Tools - Gantt, CPM, PERT.
- How to Compile - Simple Spreadsheet Techniques.
- Work breakdown Structure, Milestones, Tasks.
- Effectiveness -- Determining and Monitoring.
- A Suggested Template.
- One Major, But Often Neglected, Use.
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in project management tools and techniques targeted specifically to the regulated medical products industries, under cGMP and MDD/CE-marking compliance. It will discuss and provide examples of the most common project management tools and provide a major example for immediate use. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: - Senior management
- Regulatory affairs
- Quality Assurance / QAE
- Production
- R&D and Engineering
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
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Deadline for Abstracts:
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2011-03-08
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Registration:
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Price List: Attend Live Online Training $249.00 One Dial-in One Attendee $999.00 Group–Max. 10 Attendees (For multiple locations contact Customer Care)
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E-mail:
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referral@complianceonline.com
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