I currently work at a project-based clinical research company where I process and manufacture cell-based infusion products for the treatment of conditions that are not easily treatable (myelomas, melanoma, renal carcinomas, etc). We hold daily meetings at the start of each shift to discuss the plans/processes that are to take place for the day as well as any changes that are implemented (mainly in SOPs). Since the design meetings occur with members from all departments, changes that are department-specific are not openly discussed and are instead disclosed shortly prior to processing to ensure that the new information will be immediately remembered and applied. One downside to the meetings at my company is that certain important topics are brought up at the meeting rather than being distributed to the team members prior. As mentioned in lecture, one of the most important aspects when presenting a document in a meeting is to provide each participant with a handout of the designated document. This form of communication will allow each team member to adequately review the contents of an executed change so that it can be efficiently discussed and approved while everyone is together in the same location.

Meeting minutes are normally stored in the DHF and are commonly completed as a 1 page document. This document contains entries such as the attendees, topics on the agenda, a brief summary of the discussion following each task on the agenda, and the action items that addresses each task at hand along with their designated deadlines. A second page is usually recommended for acquiring the signatures of all attendees that states that they approved of the aforementioned items. How are non-approvals handled in meetings (i.e. meeting extensions, reschedules)? Are there other change-related documents that can be handed out during design meetings? Are meeting minutes required by the FDA? If a design team is able to communicate entirely via email/skype, then can meeting minutes be omitted from a DHF?