GLP Compliance: 10 Steps to an Audit-Ready Laboratory

Held Jan. 26, 2010

Nothing can be more demanding than FDA test-lab inspections. But don’t fret just yet – audit success boils down to 10 simple steps. Read on ...

For the testing laboratory, there’s no margin of error — no flex in FDA rules. And even though companies spend countless man-hours and millions of dollars in design, equipment, validation and testing of laboratory controls, many fail lab inspections all the same.

Success depends on learning the 10 steps to prepare for the dreaded GLP audit — the 10 key elements inspectors look for — then following them to the letter.

Do you know what they are?

Here’s the course you’ve been looking for — the training session that instills test-lab personnel, from old hands to new hires, with a zero-tolerance mindset that results in clean audits every time.

Your instructor, Chitra Edwin, PhD, RAC, has managed GLP- and CLIA–compliant laboratories, multidisciplinary project teams and collaborations. She’ll walk you through the 10 steps and supply key information including:

  1. The most important elements in lab design
  2. The 3 categories within the organizational structure — responsibilities the FDA requires the study director to do throughout the inspection process
  3. How the QA unit is involved in a study — an independent assessment increasingly important to the FDA
  4. Who is responsible for validating lab equipment and how often verification is required
  5. The 3 phases of recording and resolving procedural deviations
  6. The 4 steps in receiving materials, with special attention to handling hazardous materials
  7. Specific rules that apply to biologics
  8. When a new SOP must be created, and why
  9. Documentation management — how long must data be archived, and in what format
  10. And much more!

Using case studies, you’ll learn how to create a CAPA following receipt of a Form 483.

Plus, you’ll receive a GLP standard checklist that lets you anticipate each step the inspector will take. It’s a veritable “navigation guide” to audit readiness — yours free as a seminar participant.

That’s not all. Participants also receive a laboratory notebook template, another free bonus exclusive to this session. Lab notebooks are among the first things inspectors ask to see. This notebook template outlines how to organize your lab notebooks, and what information must be included. These two free bonuses are worth the registration fee by themselves.
Everyone in your organization with a role in making test labs audit-proof deserves to take part in this event — and they can do so, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.

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  • Test facility directors and supervisors
  • Scientists
  • Analysts
  • Maintenance personnel
  • Executive management
  • QA/ QC Auditors and reviewers
  • Regulatory affairs personnel
  • Consultants

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Chitra Edwin, PhD, RAC, is a principal with Biotechnology Consulting Solutions Ltd., helping clients with product development, technology transfer, due diligence, regulatory affairs, SBIR grant writing, scientific reports and reviews, and CRO audits. An experienced manager of GLP- and CLIA-compliant laboratories, she has overseen projects involving development of regulated therapeutic and diagnostic products from concept through manufacturing transfer.

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