Query : I'm an informally trained Project Management ... Now I am working on launching product and don't have FDA/EPA experience and we are launching product that falls under either regulation. Would this course (Project Management for FDA regulated companies) be of help?
Ans: Definitely. This course focuses on use of simple PM tools to drive FDA projects (basically PM for the non-PM certified manager). We cover 3 key tools: the Gantt Chart (emphasized), the CPM, and the PERT (with the last two considered for their network, and parallel path illustrative value); also discussing additional tools such as flow charts and cause and effect diagrams to assist in developing Milestones and Tasks.
The projects discussed with sample milestones / templates are:
- Design Control (21 CFR 820.30) / Design and Development Planning (ISO 13485:2016 7.3) for new device development;
- Product / Process / Equipment / Software Validation;
- Product Risk Management (ISO 14971);
- Use Engineering / Human Factors Engineering (IEC 62366-1:2015);
- Regulatory compliance inspection (Form 483) remediation.
Due to the short length of the presentations, only the key milestones of each are listed / discussed, but that should be enough to start on the right path to use PM tools in those areas, fleshing out the tasks under the milestones by "reverse engineering", discussed in the webinar.
Design Control does have an extensive Milestones / tasks listing, but most of the others only focus on Milestones.
Though not discussed in the webinar, one could take the 21 "tabs" of the FDA's required 510(k) submission to develop the key Milestones for a 510(k) submission as well.
jel@jelincoln.com
The 21 510(k) "tabs" have been added as project milestones discussed in subsequent versions of my Project Management webinars. - - JEL 09/20/2023
