GXP Training Course

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Who Should Attend: This is a recommended annual training course. It is designed for anyone who works at a biopharmaceutical firm. Senior, junior, technical, administrative, regulatory, manufacturing doesn’t matter. We should all know the rules and hear why they are important and how they are currently being interpreted.

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 eight 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 $2898 for all eight sessions! Great group discounts are available.

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

Session 1: GXPs and Their Legal Foundation

Session 1: GXPs and Their Legal Foundation

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● PHS and FD&C Act, FDA structure and its relationship to drug life cycles (development thru post-marketing)
    ● Rules…Regulations…Guidances: What and Where
    ● GMPs 210 and 211; The Subsections A – C: Including organization and personnel; training issues, and facilities

  • Click HERE to watch an excerpt of Session 1!

Session 2: GMP 211 Continued

GMP 211 Continued

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● Subsections D-K, with an emphasis on equipment, monitoring, laboratory controls

  • Click HERE to watch a trailer of Session 2!

Session 3: GLPs Part 58

GLPs Part 58

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● Part 58 of the regulations
    ● GCPs update

  • Click HERE to watch a trailer of Session 3!

Session 4: Keeping the GXP Frame of Mind

Keeping the GXP Frame of Mind

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● Auditing contract service providers
    ● Internal audits – GLPs vs. GMPs, GCPs

  • Click HERE to watch a trailer from Session 4!

Session 5: When Things Go Astray

When Things Go Astray

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● Failure Investigations
    ● Out-of-Specification (OOS) Results
    ○ Historical introduction, guidance review
    ○ Current inspectional findings

  • Click HERE to watch a trailer of Session 5!

Session 6: Tracking the Risk: Aseptic Processing

Tracking the Risk: Aseptic Processing

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● Clean room basics
    ● Guidance review
    ● Laboratory testing
    ● Case studies from recent inspections

  • Click HERE to watch a trailer of Session 6!

Session 7: Hot Topics

Hot Topics

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● Application Integrity
    ● QA systems
    ● Analytical Issues

  • Click HERE to watch a trailer of Session 7!

Session 8: Recent Inspection Trends and Case Studies

Recent Inspection Trends and Case Studies

  • Instructor: Dr. Laureen Little
  • Format: On-demand recording available now.
  • Content:
    ● Anatomy of an FDA Inspection
    ● Review of past years inspection trends
    ● In-depth look at the top 4 inspection issues
    ● Case studies of current 483s and warning letters

  • Click HERE to watch a trailer of Session 8!

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.