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)
  • EMA GMP Regulations
  • 21 CFR Part 11
  • Good Clinical Practices
  • Good Laboratory Practices
  • ISO 13485:2003

FDA Guidance:

  • 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

Documentation:

  • Effective SOP Writing
  • Writing Up Investigations
  • The Basics of cGMP Documentation
  • Auditing cGMP Documentation

General Quality:

  • 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

Auditing:

  • How to be Audit-Ready 24/7
  • The Basics of Internal Auditing

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."
  • "Best training ever!  Elaine rocks!"