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DHG Active Pharmaceutical Ingredients Training Program

Who Should Attend?

 

This course is intended for individuals who are involved in the production and quality management of Active Pharmaceutical Ingredients or with regulatory issues related to the production of APIs. Government investigators and industry participation with responsibility in API production, quality management, and regulatory or auditing functions will also benefit from this course.

Learning Objectives

 

At the completion of this course, attendee will have an understanding of the many facets of Active Pharmaceutical Ingredients (API) production, including manufacturing operations, facility qualification, process validation, cleaning validation and compliance.

Documentation Support

• Detailed course notes are provided in advance to be presented to each participant.
• A complete set of literature references will also be provided for future use by the participants.
• All attendees receive a certificate attesting to their participation.

Course Outline

 

This on-site course is offered in four sections:

The Drug Regulatory and Compliance Process

• API Operations in a Pervasively Regulated Environment
• Personnel Development & Training
• Master Records & Batch Records
• Process Development & Strategies
• Filings - NDA & DMF’s
• Changes to Filings - BACPAC

Operations

• Plant Controls
• Product Reworking
• Sterile Bulks API’s
• Water Systems Design & Operations
• API Impurities
• API Physical Properties
• Computer System Audits
• Parental Grades API’s
• API Stability Programs
• Laboratory Documentation Issues

FDA Inspections

• Legal Authority of the FDA to Investigate Drug Substances Operations
• Preparation for an Inspection
• Inspector Authority vs. Company Rights
• Exit Interviews
• Avoiding Regulatory Actions

Validation

• Technical Transfers
• Qualification of Processing Equipment and Support Systems
• Validation of Bulk Pharmaceutical Processes
• Cleaning Validation
• Validation of Computer Systems
• Validation of Water Systems
• Validation of Sterile APIs

 

 

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