Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow
Instructor:
Michael Esposito
Product ID: 707020
- 12
- August 2025
Tuesday - 10:00 AM PT | 01:00 PM ET
Duration: 90 Mins
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.
Learning Objectives:
- 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.
Areas Covered in the Webinar:
- Overview of API production
- API 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
Who Will Benefit:
This course will be of benefit to employees who are tasked with creating new manufacturing workflows or revising existing workflows for APIs. People working in Pharmaceutical industry, Manufacturing, Change Control, Laboratory testing, Quality Assurance, Packaging and Labeling, Inventory Management, Warehousing and Distribution will also benefit from taking this training.
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.
More Training By Experts
- Onboarding in a GMP Environment: Best Practices for Foundational Employee Success
- Best Practices of Writing SOPs
- The Importance of Packaging and Labeling in Pharmaceutical Product Development
- Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
- Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
