Regulatory Compliance Training Workshops

With our mix-and-match system, we offer a 3-step approach to curriculum planning:

  1. Pick your topic(s).
  2. Pick your presentation length(s).
  3. 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:

Regulations:
GMP Regulations (21 CFR 211)
Quality System Regulation (21 CFR 820)
21 CFR Part 11
ISO 9000:2000
ISO 13485:2003
FDA Guidance:
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
Current Summary of International Device QSR Trends
Documentation:
Effective SOP Writing
The Basics of cGMP Documentation
Auditing cGMP Documentation
Enforcing GMP Documentation Requirements
General Quality:
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
Auditing:
How to be Audit-Ready 24/7
The Basics of Internal Auditing
Mock FDA Audit Spot Check
Mock ISO Audit Spot Check (9000 or 13485)
Training:
Train-the-Skills Trainer
Effective SOP Training
Designing a Real-World GMP Training Curriculum
Assessing Training Effectiveness
Housekeeping:
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
  • PowerPoint lecture only
  • Concise summary of topic key points
  • You make copies of handouts
"Intro" Session 3 hours Maximum 20 attendees
  • PowerPoint lecture with some exercise/discussion to relate theory to practice
  • Customized exercises using actual facility data/documents
  • Consultant provides handouts
"In-Depth" Session 6 hours Maximum 20 attendees
  • Expanded PowerPoint lecture with multiple exercises/discussion for hands-on training
  • Customized exercises using actual facility data/documents
  • Consultant provides handouts

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."