Regulatory Compliance Training Workshops
With our mix-and-match system, we offer a 3-step approach to curriculum planning:
- Pick your topic(s).
- Pick your presentation length(s).
- Pick your date(s).
That's all there is to it - you now have your compliance training curriculum and schedule completed! You can set up plans based on training hours/employee, or focus on training by topic categories for maximum impact. (Of course, custom program topics and lengths are always available too.)
Representative Session Topics:
- GMP Regulations (21 CFR 211)
- Quality System Regulation (21 CFR 820)
- EMA GMP Regulations
- 21 CFR Part 11
- Good Clinical Practices
- Good Laboratory Practices
- ISO 13485:2003
- Risk Management
- Quality Systems Approach to Pharmaceutical cGMP Regs
- Sterile Products Produced by Aseptic Processing
- PAT: A Framework for Innovative Pharma Development
- Current Summary of International Pharma GMP Trends
- Effective SOP Writing
- Writing Up Investigations
- The Basics of cGMP Documentation
- Auditing cGMP Documentation
- Minimizing Human Error
- Basic GMP for Temps
- The Production Cycle and Regulatory Compliance
- GMP in the Labs
- Designing, Auditing, Improving Your Quality System
- Supervising in a GMP Environment
- QA-Manufacturing Teamwork
- How to be Audit-Ready 24/7
- The Basics of Internal Auditing
- Train-the-Skills Trainer
- Effective SOP Training
- Designing a Real-World GMP Training Curriculum
- Assessing Training Effectiveness
- Cleaning Up - GMP Housekeeping Strategies to Prevent Contamination
Program Length Options:
|Session Type||Session Length||Maximum Audience||Format/Notes|
|"Info" Session||1.5 hours||Unlimited attendees||
|"Intro" Session||3 hours||Maximum 20 attendees||
|"In-Depth" Session||6 hours||Maximum 20 attendees||
Many titles offer all 3 presentation length options; a few, due to their nature, offer less options. Don't see your topic? E-mail or call and ask us!
What Attendees Have Said About Our Courses:
- "Time and money well invested."
- "Excellent presentation and hands-on mix. Will be very valuable to me immediately at work! Thanks."
- "It was a pleasure to participate."
- "Best training ever! Elaine rocks!"