Government Contract Requirements for Pharmaceutical Products
Michael Esposito Overview:
Labeling to satisfy the requirements of federal government contracts has its own unique requirements. In this webinar, we break down both the requirements and what a typical process would look like.
Why you should Attend:
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.
Key learning objectives of the topic:
- 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
Areas Covered in the Session:
- 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)
Who Will Benefit:
- 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
Speaker Profile
Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 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 workplan for McNeil and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and 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, and sustainable packaging.