GLP Compliance10 Steps To An Audit Ready Laboratory

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You can count on death, taxes ... and GLP inspections.

They’re no fun to undergo, but possible to pass with the proper preparation.

To find out how, read on.

GLP inspections are like taxes: Hard to avoid, and just about as much fun.

If you’ve ever been through a GLP inspection — and few drug or biologics execs have not — you don’t look forward to the next one. But as with taxes, you know the day must come.

This time around, why not ease the pain? Why not start getting ready now?

Sign up for the GLP “boot camp,” sponsored by FDAnews and conducted by a top consultant in GLP and QA training, Anne Maczulak of Acorn GLP Consulting.

In only 90 minutes, you’ll learn (or re-learn) the basics — the 10 steps that make short work of preparing for an inspection. By the end of the webinar, you’ll feel more secure about being in compliance and avoiding 483s or warning letters.

Specifics? Here’s a partial list:

  • The most important elements when creating the design of the laboratory
  • Universal vs. science-specific steps to auditing your laboratory
  • 5 essential hosting jobs and their requirements
  • Who is responsible for validating equipment and how often they must be verified
  • How to determine your company’s chain of custody (COC)
  • Which information belongs in a lab notebook and how to organize it
  • Emergency procedures: When to put them in an SOP vs. a non-SOP format
  • Creating report templates to meet FDA and industry standards
  • How to manage out-of-service equipment and still be compliant
  • 2 elements of documentation management: How long to archive data, and in which format
  • And much more!

GLP Compliance: 10 Steps To An Audit Ready Laboratory is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your home office.

And because the seminar is fully interactive, you’ll have plenty of time for answers to all your questions. Just send them in by e-mail, and watch for the answers by the time the session ends.

Preparing for inspections is the work of many hands. You’ll want to sign up dozens of colleagues and staff for this event — and luckily, it costs just one low registration fee to do so.

There’s no limit on number of participants as long as they’re at the same facility. Generous multi-site discounts are available too — just call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about multi-site discounts.

GLP inspections reward the well prepared. If it’s been a while since your last one, here’s a golden opportunity to catch up — a “refresher course” that takes just 90 minutes out of your day, but could save you months of headaches — not to mention FDA sanctions. Seize this opportunity.

Sign up now

If you work in drug or biologics manufacture, this webinar is a perfect opportunity to acquire new skills or brush up old ones. It’s perfect for:

  • Test facility directors, supervisors, scientists, analysts and maintenance personnel
  • Executive management
  • QA/QC Auditors and reviewers
  • Regulatory affairs personnel
  • Consultants

Anne Maczulak PhD, RQAP-GLP, is Principal Consultant of Acorn GLP Consulting, a California firm specializing in helping laboratories new to preclinical work build strong quality assurance and GLP programs. A trained microbiologist, Ms. Maczulak consults in the areas of environmental monitoring and development of HACCP programs.

She has presented training in quality assurance for ComplianceOnline, the National Society of Quality Assurance and other organizations. She is the author of the Encyclopedia of Microbiology (2011); Allies and Enemies: How the World Depends on Bacteria (2010); The Five-Second Rule and Other Myths about Germs (2007); and “Green Technology (2010),” an eight-book set for grades 9-12.

Register now!

Date: April 11–29, 2011
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.

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
with any questions.

We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

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