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Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow
- Overview of API producAPI in the context of project management
- Drug types that warrant special consideration
- Laboratory testing and possible product defects
- Batch review and approval/rejection
- In-house labeling and warehousing of API
- Packaging and distribution of bulk product
- Bulk product intended for creating finished package
Overview of the webinar
Mapping and evaluating all the steps in a current pharmaceutical ingredient bulk manufacturing 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.
Who should attend?
This course will be of benefit to employees who are tasked with creating new manufacturing workflows or revising existing workflows for APIs.
It is particularly valuable for professionals working in the following areas:
- Pharmaceutical industry
- Manufacturing
- Change Control
- Laboratory testing
- Quality Assurance
- Packaging and Labeling
- Inventory Management
- Warehousing and Distribution
Why should you attend?
This course will describe the basic elements of pharmaceutical ingredient bulk manufacturing 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 active pharmaceutical ingredient (API).
- 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 defects that can exist with tablets, capsules, and other dosage forms.
- Account for specific reasons for deficient product and means of resolution.
- Consider the requirements for warehousing once API is produced.
- Review workflows once created and documented to achieve process improvements.
Faculty - Mr.Michael Esposito
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 and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.