Mapping and evaluating all the steps in a pharmaceutical manufacturing and packaging workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.
This course will describe the basic elements of pharmaceutical manufacturing and packaging and give you the tools that can help you develop a new workflow or improve upon an existing workflow.
This course will describe the basic elements of pharmaceutical manufacturing and packaging and give you the tools that can help you develop a new workflow or improve upon an existing workflow.
Learning Objectives
- Describe general information related to the manufacture of finished pharmaceuticals and packaging.
- Outline the factors to keep in mind when manufacturing certain drug types (e.g., penicillin).
- Describe the parameters of laboratory testing and Quality Assurance acceptance or rejection of batches.
- Articulate the types of errors that can occur within the manufacturing and packaging workflows.
- Investigate and determine root cause(s) for errors and design corrective and preventive actions (CAPAs).
- Articulate the requirements for transfer of product to warehousing and distribution.
- Review workflows once created and documented to achieve process improvements.
Course Content
- Overview of finished product manufacturing
- Importance of packaging in the finished product process
- In-house verification methods (e.g., bar codes)
- Laboratory testing and possible product defects
- Finished product batch review and approval/rejection
- Packaging and distribution of finished product
- Considerations related to product intermediates
- Labeling and transfer of finished product to warehousing and distribution
Speaker
Michael Esposito has 30 years experience in the pharmaceutical industry and 13 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 organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.
