Quality System Regulation Training: 21 CFR 820 and ISO 13485

Over the last twenty years, FDA and manufacturers have used the current Good Manufacturing Practices (cGMP) under Medical Device Quality System (QS) regulation) (21 CFR part 820) to ensure the required methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of medical devices. The Agency understands and appreciates the need for Quality Management System (QMS) requirements that can apply to both large and small U.S. manufacturers for streamlining and harmonizing the standards for quality systems. As the Agency continues to apply least burdensome concepts for regulations, we recognize there is a need for a globally unified quality system that will reduce burdens to both industry and FDA. FDA intends to harmonize QMS requirements for medical devices with the International Standards Organization’s (ISO) requirements for medical devices under the ISO 13485 (QMS Standard). The standard specifies requirements for a QMS where a manufacturer needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is comparable to the QS regulation, with some exceptions as it includes many of the essential requirements for ensuring manufacturing of reasonably safe and effective medical devices. 1. Purpose The purpose of this contract is to procure the Commercial Off the Shelf (COTS) in fully virtual format courses; Quality System Regulation Training: 21 CFR 820 and ISO 13485 to ensure CBER staff are able to explain the scope and applicability of the requirements of 21 CFR 820 and ISO 13485. 2. Scope of Work CBER needs a commercial contractor to provide two sessions of the above course in a fully virtual format for four days for 1st session 1-50 learners and the 2nd session 1-20 adult learners to support their learning and development needs. Depending on fully virtual format space, this could involve more than one course to ensure all personnel are trained. This scope consists of four (4) functional task areas, including, but not limited to: Training Requirements Training Instructor Qualifications and Expectations Training Facilities Class Materials Task Areas Support in the following Task Areas are required under this contract. This list is not all inclusive, and additional tasks may be required. 3.1. Task 1: Training Requirements 3.2. Task 2: Training Instructor Qualifications and Expectations 3.3. Task 3: Training Facilities 3.4. Task 4: Class Materials