Pharmaceutical Manufacturing Hands-On Short Courses

FDA-26-PWS-135130 Statement of Work Pharmaceutical Manufacturing Hands-On Short Courses 1. BACKGROUND The Office of Quality Surveillance is requesting to send up to 40 personnel to a pharmaceutical manufacturing short course which provides both hands on and lecture capability. OPQ requires an interactive course that will provide staff with an overview of pharmaceutical manufacturing. Examples of topics of interest include tableting, aseptic processing, granulation, lyophilization, fermentation, ultrafiltration/diafiltration, filling, and film-coating. 2. PURPOSE AND OBJECTIVES The objective is for OPQ staff to understand the pharmaceutical manufacturing process from the raw material assessment and formulation development through end-product testing and quality control. This course will allow students to go through the entire manufacturing process from start to finish in a systematic way, allowing comprehensive understanding of critical pharmaceutical manufacturing unit operations. This course is ideal for FDA regulators who work on surveillance and assessment of CDER-regulated facilities and the drug products that they manufacture. 3. SCOPE OF THE WORK The Pharmaceutical Manufacturing Short Course shall offer five (5) (8-hour/day) sessions in- person, including a group kickoff session, group closeout session, class materials (Book/eBook and homework), list of resources/references, knowledge checks, and certificates of completion. Basic requirements for the short course include: • Develop a basic understanding of the principles of the unit operation(s) • Setup, operation, cleaning, and maintenance of the equipment • For the unit operations studied, understand the basics of process control and monitoring. • Identify key variables that control the product quality • Hands-on demonstration of the unit operation(s), including critical steps 4. DELIVERABLES • Training for up to 40 employees for up to five days not exceeding eight hours each day, including a final knowledge check quiz or exam • Certificates of completion to be maintained as part of the training record • Pre-training reading package or background materials to establish baseline knowledge -- 1 of 6 -- among participants • Case study materials tailored to pharmaceutical manufacturing scenarios for use during training sessions • A curated resource list of relevant FDA guidances, ICH guidelines, and key scientific literature provided to participants following each session 5. CONTRACTOR QUALIFICATIONS • Direct experience with pharmaceutical manufacturing, including key processes involved in solid oral manufacturing, aseptic processing, and/or biopharmaceutical manufacturing. • Deep familiarity with the regulatory and scientific frameworks governing pharmaceutical manufacturing and relevant FDA regulations, guidance documents, and policies such as those addressing process validation, PAT, data integrity, and quality systems. • Credentials or demonstrated experience developing and delivering adult learning curricula, preferably to regulatory scientists, inspectors, or other technical audiences. • Experience delivering training to regulatory or scientific audiences is strongly preferred given the technical nature of the subject matter and the FDA audience 6. PERIOD OF PERFORMARNCE The period of performance shall be a five (5) day period in which five (5) 8 hour training sessions that will be scheduled within one year from the date the contract is awarded. 7. PLACE OF PERFORMANCE Work shall be performed at a location identified/provided by the contractor. 8. CONTRACT TYPE Firm Fixed Price 9. GOVERNMENT-FURNISHED PROPERTY/INFORMATION The Government shall provide technical points of contacts for the training. 10. SECURITY AND CONFIDENTIALITY REQUIREMENTS Performance of work will not require contractors to have access to and use of data and information that may be considered proprietary to regulated industry, a government agency or Government contractor, or that may otherwise be of such nature that its dissemination or -- 2 of 6 -- use would be averse to the interest of FDA or others. Contractor shall be responsible for knowledge of and compliance with all applicable federal information. 11. ACCEPTANCE CRITERIA All deliverables shall be subject to FDA review and acceptance. Deliverables must: • Be complete, accurate, and professionally prepared • Meet the requirements specified in this SOW • Be submitted in the formats specified by the COR • Be accepted in writing by the COR within 15 business days of submission Deliverables not meeting acceptance criteria shall be revised and resubmitted within 10 business days of notification. 12. GOVERNMENT POINTS OF CONTACT Contracting Officer (CO): Kyle Smith Contracting Officer's Representative (COR): TBD Technical Point of Contact: TBD 13. CLAUSES / INSTRUCTIONS / EVALUATION HHSAR 352.211-1 Public Accommodations and Commercial Facilities (Nov 2025) (RFO DEVIATION) (Full Text) (a) The Contractor must submit an approved plan ensuring events comply with 28 CFR part 36 (disability access) to the Contracting Officer Representative prior to the event, covering all, or a master plan for, events. (b) The contractor must manage the contract to comply with 28 CFR part 36 standards. (End of clause) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR 352.224-70, Privacy Act (Dec 2015) HHSAR 352.232-71, Electronic Submission of Payment Requests (Feb 2022) General FAR Clauses (Incorporated by Reference) • FAR 52.04-13, System for Award Management Maintenance (Oct 2018) • FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) • FAR 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) • FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services (Nov 2023) • FAR 52.212-3, Offeror Representations and Certifications—Commercial Products and -- 3 of 6 -- Commercial Service…