Mapping and Review of Pharmaceutical Manufacturing and Packaging Workflows

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.

• 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.

• 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

This course will be of benefit to employees who are tasked with creating new manufacturing workflows or revising existing workflows for finished product and packaging. This course will also benefit those working in Pharmaceutical, Manufacturing, Change Control, Laboratory testing, Quality Assurance, Packaging and Labeling, Inventory Management, Warehousing and Distribution industries.

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.