Added: Aug 15, 2008 2:20 pm
Statement of Work for GAMP 5 Training
June 18, 2008
1. PURPOSE/OBJECTIVE:
The purpose of this Statement of Work (SOW) is to elicit proposals to provide a Good Automated Manufacturing Practices v.5 (GAMP5) training course specific to validation and information technology (IT) professionals of the US Army Medical Research & Materiel Command (USA MRMC). This course shall be conducted by contractor staff. The course encompasses course outline, training aids, and course materials. The contractor shall provide a GAMP5 training course tailored to USA MRMC needs.
The training shall cover the overall GAMP 5 principles, including the life cycle framework and the corresponding activities applicable to GxP regulated computerized systems.
2. ENVIRONMENT:
The FDA requires all computerized systems used for clinical trials which contain electronic records and/or electronic signatures to be validated for its intended use. Computer system validation requirements are specified in the FDA documents referenced below. It is important for all individuals involved in the selection, implementation, and administration of a computerized system to understand the FDAs expectations to have training that covers the basics of computer system validation, as well as courses specific to the needs of the employee.
3. REFERENCES:
These are the basic references used to ensure that the tasks conducted, recommendations made, and products delivered are consistent with government requirements. These references are not intended to be all-inclusive. The following abbreviations are used:
FDA Food and Drug Administration
GAMP Good Automated Manufacturing Practices
ITIL Information Technology Information Library
GCP Good Clinical Practices
The following references are cited:
FDA:
Guidance for Industry: Computerized Systems Used in Clinical Investigations
21 CFR Part 11: Electronic Records; Electronic Signatures
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application
ORA FIELD MANAGEMENT DIRECTIVE No. 146: Electronic Records: Electronic Signature Certification
Industry:
GAMP 5
ITIL
4. SCOPE OF WORK:
The contractor shall provide a participant material packet for a classroom-based course. The participant material packet will provide the participant with the materials discussed in the course for future reference. The participants materials shall be bound. These items shall be included in the participant materials: a table of contents; a list of frequently used acronyms; approximate time estimates to present each section; references to other manuals and guides on validation and clinical practices; and hardcopies of the transparencies.
5. TASK DESCRIPTIONS:
Task 1 - Provide Course Outline
The contractor shall provide a statement of the contractor's approach to the training. The contractor shall provide a lesson plan and supporting course material for the validation and IT professionals of the USA MRMC. The guidelines for this task are GAMP5. The class at a minimum shall cover the following topics at the appropriate level of detail for validation and IT professionals of the USA MRMC: roles and responsibilities relative to the establishment, implementation, and monitoring of GAMP5 compliant information system; considerations for Internet, Web, and the System Life Cycle. The target length of the class should be two (2) days or other length with justification. The contractor shall present the Lesson Plan and Supporting Course Material to the USA MRMC staff.
Task 2 - Conduct Class for validation and IT professionals of the USA MRMC
The contractor shall conduct a class for validation and IT professionals of the USA MRMC and use a suitable evaluation methodology to measure class results.
Task 3 - Course Materials and Certificate of Completion
The contractor shall provide the Participant Material Packet and a Certificate of Completion to course attendees. The Certificate of Completion shall include the date of the course, the name of the instructor, and the name of the individual receiving the Certificate.
6. DELIVERABLES:
All deliverables submitted under a transmittal letter that will identify the contract shall accompany contract and the products presented. A copy of each transmittal letter will be forwarded to the Contracting Officer for inclusion in the contract file.
DELIVERABLES DUE DATE
Provide Course Outline Date of Training
Conduct Class Date of Training
Provide Participant Course Material Date of Training
Provide Certificate of Completion Ten working days after completion*
* (working days from last day of training)
7. TECHNICAL CONTACT AND OTHER:
c. OTHER: Government-Furnished Equipment (GFE)/Government-Furnished Materials (GFM):
USA MRMC shall furnish the space in which the training will be conducted, and the necessary audio/visual equipment.
