SAM #FDA-26-PWS-135130

FDA Solicits Hands-On Pharmaceutical Manufacturing Training for 40 Personnel

The Food and Drug Administration (FDA) Office of Quality Surveillance is seeking a contractor to deliver a five-day, hands-on pharmaceutical manufacturing short course for up to 40 personnel. - Government Buyer: - Food and Drug Administration (FDA), Office of Quality Surveillance - Scope of Services: - Five (5) 8-hour in-person training sessions (totaling 40 hours) - Up to 40 FDA personnel to participate - Course must include both hands-on and lecture components - Topics to cover: tableting, aseptic processing, granulation, lyophilization, fermentation, ultrafiltration/diafiltration, filling, and film-coating - Deliverables: training sessions, certificates of completion, case studies, and resource lists - Requirements: - Contractor must have demonstrated pharmaceutical manufacturing experience and regulatory knowledge - Proposals must include instructor qualifications, curriculum alignment, and past performance references - No specific OEMs or vendors are named in the solicitation - Emphasis on interactive, practical training and regulatory relevance

Description

Requesting to send up to 40 personnel to a pharmaceutical manufacturing short course which provides both hands on and lecture capability. 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.

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