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
• 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: