Primary Student Objectives - General High Level Topics where we will move down to very specific discussion and details to generate a much higher comprehension for quality individuals even though during this course you will not have to take a final exam!
Upon completing this course participants will gain a much better Quality Systems comprehension, based on the instructor's decades of experience helping generate quality system regulations, working with the FDA, fixing FDA findings and generating a synergistic discussion with the attendees to help us all make sure we understand that there is rarely ever on "one" way to do things or "right and wrong", just like making an assumption about the Root Cause of an incident rather than working together to realize there are other things that took place that the individual making the assumption may not have been aware of.
1. What is expected from the QA professional and how other industries (FAA, ISO, EPA, etc.) have made Quality Systems so profitable by having the Head of Operations and the Head of Quality trading places every 6 months.
2. Gaining a more practical Comprehension from experience of the Quality Systems regulations not just reading and thinking you are an expert (reading three books on how to ride a bicycle does not make you an expert).
3. Once we have a better perspective then we will identify the necessary activities like working on a thesis to generate the needed performance for the entire Quality System.
4. How to apply current technology to generate the objective evidence needed to generate the attitude of making the FDA successful when inspecting by answering all the potential inspector questions before asked. Use the applicable technology to think like an FDA inspector
5. How are we going to maintain documented evidence to prove that the process and initial validation is still working in accordance with the Quality System regulations
6. Make sure we have the proper tools and comprehension to perform the needed internal audits which ensures that when a client audits the company or the FDA inspects the facility, we have already been doing all the things they might be reviewing.
7. Making sure that all the laboratory, inspection, calibration, and related quality verification activities are working in a way that generates higher profitability by generating continuous quality improvement (CQI)
8. Ensuring that vendors are practicing the similar quality performance to make sure we don't get hit by their lack of consistency and quality performance based on the needed specifications for our process or products.
9. Defining the expected although not actually defined by the FDA what we need to demonstrate GDP (good documentation practices) which also serve as "legal" documents if something negative happens.
10. Management of Incidents, Deviations, Changes - Incident tracking systems(ITS), deviation management (OOS, OOT, OOL, etc), Critical Change Control (CCR) and Corrections, Corrective Action and Preventative Action (CAPA).
11. Batch Production Record (BPR) or Device History Record (DHR) related to the master versions of the documents used for production and the review before release.
12. How to use statistics for Quality Systems and make sure that 6 Sigma is not being used during the validation activities.