It 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. Three of the most common tools will be discussed.
Common varients such as `dashboards` will also be presented. A very simple approach using common Excel- or Word-type PC applications programs that can be used immediately will be highlighted. Regular use of a few simple but powerful tools will virtually eliminate `fire fighting` in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is running out, increased product liability, assist in company-wide cost reduction efforts, with less chance of recalls, and an improved bottom line.
Why you should 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 ommitted until late in the project when disaster looms? How to minimize scope creep? What are the `lean` and `Agile` benefits and shortcomings in the cGMP environment? What is `failing fast` in the `build-measure-learn, re-evaluate / decide loop? How to gain management support for the Milestones, Tasks, 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.
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`.
Speaker
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.
Who Should Attend
- Senior management in Drugs, Devices, Biologics, Dietary
- Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with project leadership responsibilities
