I have worked in the past at a fairly large pharma, which had a very thorough QMS system. Advantage of this, is that everything is kind of well characterized, drawback, a lot of paperwork to shift through during training.

I have also worked at a small start-up, nutraceutical, and was there during the actual QMS setup phase. In order to…[Read more]

For low severity of risk I would choose acceptance. If a risk is acceptable, it should be low by default. High risk items should be mitigated down to a medium or low risk whenever possible. I don’t think avoidance reduces the risk level out of the severity of a risk. I view avoidance as brushing something under the rug and hoping i…[Read more]

Meeting minutes may not seem important until you need them. In one case, I was in a meeting where I was aware of what was said and agreed to but did not remember the specific date and person who made an agreement to something. I sorted through emails until I found the set of meeting minutes that would allow me to justify calling…[Read more]

I don’t have personal experience with design review meetings however; I have a friend who has some experience in such meetings. The design review process itself could happen in stages. As you mentioned, a design review could last hours to weeks depending on the complexity of the project and interests of the stakeholders involved. A g…[Read more]