Basic GMPs for Early-Stage Companies

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Who Should Attend: This course is designed for anyone who works at an early-stage biopharmaceutical firm. All functions in the facility: technical, administrative, regulatory, manufacturing, quality assurance, and all levels from the most senior to the most junior staff member will benefit from this course.

Click on the titles below to learn more about each session. When live sessions are available, sign up anytime and receive links to recordings of any individual sessions or all six sessions. Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course.

Each 90-minute session is just $362 per session or $2172 for all six sessions! Great group discounts are available.

FREE EXCERPT! Want a preview of Session 1 from the GMP Course?
Click HERE to watch an excerpt from Session 1 anytime.

Session 1: Introduction to the Product Development Cycle and the PHS & FD&C Acts

Session 1: Introduction to the Product Development Cycle and the PHS & FD&C Acts

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content: Product Development Cycle: Pre-Clinical; Phase 1; Phase 2; Phase 3 – The purpose and how this alters your testing, manufacturing and concerns. The PHS and FD&C Act, FDA structure and its relationship to product life cycles – Safety, Efficacy and Consistency.

  • Click HERE to watch an excerpt of Session 1!

Session 2: cGMPs for Toxicology Studies and Phase 1 Human Studies

cGMPs for Toxicology Studies and Phase 1 Human Studies

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content: In-depth look at the critical quality attributes of the Toxicology batches and phase 1 batches, and the cGMPs required to ensure safe and efficacious product for pre-clinical and early clinical trials.

Session 3: cGMPs for Phase 2 and 3 Human Clinicals

cGMPs for Phase 2 and 3 Human Clinicals

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content: Phase 2 is considered the “sweet spot” for making changes to your process and improving your analytical test methods. Therefore, documentation and change capture (and control) are central activities. cGMPs evolve significantly during this time and near commercial levels as you proceed through phase 3 manufacturing. This session covers the requirements and practical how-to tips.

Session 4: Making the Jump to cGMPs for Commercial Products

Making the Jump to cGMPs for Commercial Products

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content: Moving from Phase 3 cGMPs to Commercial cGMP is a big step. In this session, we will explore the expected risk analysis and how it impacts your cGMP practices. We will also cover the USFDA part 211 cGMPs. This will include some recent inspections, as well as an overview of the regulations.

Session 5: Application Integrity Issues When Manufacturing Clinical Materials

Application Integrity Issues When Manufacturing Clinical Materials

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content: The recent approval of Zolgensma, the second approved gene therapy product in the US, was immediately overshadowed by problems resulting in the FDA looking at application integrity. The result is the entire biopharma industry is now revisiting their SOPs and documentation during clinical development. A focus on lab results.

Session 6: Recent Pre-Approval Inspection Results

Recent Pre-Approval Inspection Results

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content: FDA audits, risk-assessments for PAI inspections, recent trends and hot topics from recently issued 483 and Post-Approval commitments will be discussed.

COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant.  For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.