This Project Management training for FDA Regulated Companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
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.
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, Timelines?
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.
We will discuss three of the most common tools used. "Hit the ground running" with one very simple approach using common Excel- or Word-type PC applications programs will be presented. Learn how regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project.
Attend this training to understand how you can reduce scheduling uncertainty, aid project team communication, prevent incomplete projects when time is running out, decrease+C18 product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.
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
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which has been as a full-time consultant. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He has used the techniques discussed in this webinar in the actual field. He specializes in QA/RA / problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment, QMS/software 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). John also has prior experience in military, government, electronics, and aerospace. He's published many articles in peer reviewed journals, conducted workshops and webinars worldwide on virtually all CGMP activities. John is a graduate of UCLA.
