Description
We work in a highly regulated environment, which entails biennial inspections from the regulatory authorities. These regulations exist to keep our pharmaceuticals safe and healthy. The regulations, the cGXPs, are at the same time specific, vague and interpreted differently across the years. To instill a compliant culture at your facility, it is recommended that all your personnel receive cGXP training annually. However, let’s face it, this training can be dull, a bit point-missing and do a poor job at engaging your audience. This course is designed to train and engage. It covers the basic regulations, but really brings out the c(urrent) in cGXP by discussing case studies and giving specific tips and examples. And best of all, a test is available for all attendees. Once this is passed (80% correct), each attendee can be awarded a completion certificate for their training file.
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!
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!
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!
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!
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!
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!
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!
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