WebAn investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Case histories include the case report forms and supporting data including ... Web(a) General requirement. An employer shall maintain records of its anti-drug and alcohol misuse program as provided in this section. The records shall be maintained in a secure location with controlled access. (b) Period of retention. In determining compliance with the retention period requirement, each record shall be maintained for the specified …
FDA Issues Recordkeeping Rule and Guidance for Industry
WebRecord retention requirements include: ... FDA’s Record-Access Authority. Under FSMA, the FDA has the legal right to request any records associated with the manufacturing, processing, packing, or holding of … csc playoffs
eCFR :: 21 CFR Part 820 Subpart M -- Records
WebJan 17, 2024 · (2) Records that a facility relies on during the 3-year period preceding the applicable calendar year to support its status as a qualified facility must be … WebAn intricate part of my success is a philosophy that uses a non abrasive approach by implementing small incremental change that offers a long … WebMar 8, 2024 · Scott, There is an amendment in the MDD. Refer HERE under which one of the amendments is that Record retention periods have been revised to 15 years for implantable devices. This MDD will be effective as of … cscp learning system contents