Improve Your GMP Compliance With Innovative Employee Training: Nine Small-Group Exercises That Work

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Could a small change in how you train employees make a huge difference in boosting quality and avoiding costly FDA warning letters and Form 483s?

Absolutely! “Insufficient training” is frequently cited by inspectors. Now, an innovative small-group approach helps you defuse this trigger so your odds of sailing through inspections soar. And when every member of your workforce actively applies SOPs and GMPs to their own real-world situations, you will see quality soar too.

Better yet, this innovative small-group approach can deliver these results even as your training budget shrinks.

Here’s how to get on board …

Small-Group Training Makes Make Big Improvements in Compliance

Need to boost compliance with SOPs and FDA regulations? Need to make those improvements fast and on a tight budget?

Regulatory training expert Barbara Immel says the key is to trade old training methods for nine small-group training exercises that can deliver immediate compliance — and quality — breakthroughs for companies of all sizes.

In this 90-minute Encore presentation, you’ll learn how to use nine highly effective small-group learning experiences to engage your workforce in applying regulations and guidance documents to real-world situations. In addition, you’ll learn how to choose which of the nine exercises will have the biggest impact for your firm — and how to measure success.

Sign up your entire team to turbo-charge compliance training and learn how to:

  • Leverage small-group exercises for maximum retention and application of learning
  • Engage everyone in brainstorming where and how to improve
  • Prepare for the most difficult FDA questions — before inspectors arrive
  • Use other firms’ warning letters to spot and fix similar compliance issues in your own operation
  • Turn the FDA’s inspection manual into your own troubleshooting checklist
  • Create highly effective GMP review sessions that get everyone involved
  • Identify potential SOP problems — before inspectors can cite them
  • Review and implement ICH guidelines on stability
  • Conduct mock failure investigations to drive out weak links
  • Manufacture fake “products” following cGMPs

As an attendee, you’ll also receive two complimentary best-practice white papers on training. Plus, you’ll get an opportunity to address your specific concerns during the Q&A session.

This presentation is a must for positions throughout drug and device companies, including:
  • Compliance officers
  • General/corporate counsel
  • Regulatory/legislative affairs professionals
  • Training managers and coordinators
  • Operations
  • Manufacturing
  • Plant engineering
  • QA/QC
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
  • QA/QC staff
  • Executive management

Barbara Immel is president of Immel Resources LLC, a management consulting firm specializing in quality assurance, training and regulatory compliance. Barb has been teaching well-respected compliance classes for more than 20 years. She is chair of the annual FDA Inspections Summit hosted by FDAnews. She served as compliance columnist for BioPharm magazine for more than 10 years. She has taught industry subjects at the University of California at Berkeley, Stanford University, the University of Wisconsin at Madison, and the University of Georgia. Barb was elected by her peers to serve on two national training committees for PMA/PhRMA and PDA, where she helped to plan and organize conferences for industry trainers for eight years.

Register now!

Date: May 4–22, 2009
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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