Government Contract Requirements for Pharmaceutical Products

This course will describe the development of labeling for federal government contracts and give you the information that can help you develop an efficient workflow.

• Outline the labeling requirements for government contracts
• Interact with your intraorganizational liaison to review and reply to government bids
• Maintain contact with your company’s inventory management to assess the feasibility of satisfying the requirements of the contract
• Develop labeling that satisfies government requirements
• Ensure on-time delivery of orders to the government
• Manage the unique timetable of seasonal vaccines

• What makes government contracts unique
• Reviewing bids and determining if compliance is possible
• Government requirements for quantity and units per shipping container
• Reviewing production schedules and units to be produced
• Scheduling the creation of unique labeling
• Proofreading government labeling
• Prioritizing orders for seasonal vaccines (e.g., flu, COVID-19)

This course will be of benefit to employees who are tasked with responding to requests for government contracts and stakeholders within your organization, especially in the supply chain.

Instructor Profile:

Michael Esposito

Principal, TrainReach Consulting, LLC

Michael Esposito has over 30 years’ experience in the pharmaceutical industry and over 20 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree work plan for McNeil and revised their introductory GMP course. He is a member of the training organization Association for GxP Excellence (AGXPE) and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, product security, and sustainable packaging.