Breaking Down CMC & Its Roles In Drug Development Course Outline

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Who Should Attend: This course is recommended for professionals involved in drug development who work within, or adjacent to, CMC functions, including scientists, engineers, regulatory affairs personnel, consultants, and project managers. It is also recommended for researchers and academics seeking to expand their knowledge of CMC strategy and operations for biopharmaceutical development.

Click on the titles below to learn more about each session. When live sessions are available, sign up anytime during the 8-session live course! You will receive recordings of past sessions and invitations to join upcoming live sessions. Or sign up to receive links to recordings of any or all sessions as soon as they are available.

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 live session is interactive: Login, listen, learn and ask questions!

Session 1 is FREE! Each 60-minute session is just $339 per session or $2373 for all eight sessions! Great group discounts are available.

Click the button below to watch the FREE recording of Session 1: An Introduction to CMC!

Free CMC Session 1 Recording

Session 1: An Introduction to CMC

An Introduction to CMC

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • CMC: It’s definition and why the taxonomy of CMC is kind of frustrating
    • CMC Trends
    • Rules…Regulations…Guidances: What and Where
    • Module 3 – What is it? What goes in it? What goes wrong with it?
    • Navigating CMC Stakeholders & CMC Drivers
    • CMC in a Due Diligence Context
    • What Does A CMC Development Plan Look Like?
Free CMC Session 1

Session 2: Manufacturing – The ‘M’ in CMC

Manufacturing – The ‘M’ in CMC

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • The Hand-Off from Research
    • Strategic Anchors – TPP, QTPP and others
    • Drug Substance vs. Drug Product
    • What Does “Phase Appropriate” Mean?
    • Risk – Identification, Mitigation, and Acceptance

Session 3: Raw Materials

Raw Materials

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • Cell Banks & Other Custom Raw Materials – Buy or Build?
    • Chemicals & Reagents
    • Single-Use Consumables

Session 4: Process Development 1

Process Development 1

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • CQAs
    • Developability Studies
    • Upstream Process Development
    • Downstream Process Development
    • Analytical Development
    • Process Characterization & Design of Experiments
    • Quality by Design vs. Design for Manufacture
    • The Process Development Lifecycle

Session 5: Process Development 2

Process Development 2

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • Design of Experiments
    • API Process Development
    • DS Process Development
    • Formulation & DP Process Development
    • CQAs CPPs and KPPs

Session 6: cGMP Manufacturing

cGMP Manufacturing

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • Scale-up Considerations
    • Tech Transfers – Internal & External
    • Process Validation
    • Managing a Manufacturing Unit

Session 7: Operational Excellence & Risk Management

Operational Excellence & Risk Management

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • Lean
    • Six-Sigma
    • Risk Management

Session 8: MFG Audit Readiness & Case Studies

MFG Audit Readiness & Case Studies

  • Instructor: Brian Tham
  • Format: On-demand recording available now.
  • Content:
    • The Paper Component
    • The IT Component
    • The Human Component
    • Case Studies

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.