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Risk-Based Clinical Quality Assurance
Train Your Auditors Like The FDA Does
New in 2014 — One-of-a-kind workshop teaches proven tips and tricks for training your auditors to spot even the slightest violations — before the FDA does.
In two action-packed days, you'll learn what FDA investigators use to evaluate your sites. This interactive workshop will teach you how to develop risk-based CQA processes and compliance readiness.
You'll benefit from the first-hand knowledge and experience of workshop leader and expert Michelle Sceppa, a 25-year quality assurance and regulatory compliance veteran in both the pharmaceutical and medical device industries.
Some of the most common Form 483 citations issued to clinical sites include:
- Failure to follow protocol — a clinical investigation was not conducted in accordance with the signed statement of the investigator
- Case history reports that are inaccurate or inadequate
- Failure to obtain consent forms — or the consent forms were not approved, signed or dated
Any one of these could derail your project, costing you millions in lost revenue. On June 18-19 in Bethesda, MD, auditing veteran Michelle Sceppa walks you step by step through such details as:
- A review of how FDA conducts clinical inspections and the top 5 GCP violations
- How to write GCP audit SOPs — what elements to include
- Writing a central laboratory audit SOP and why you need this SOP
- Selecting sites to be audited — creating a master audit plan and how to make sure it is met
- Audits of a central laboratory — why lab data and testing are a critical component of the clinical study
Throughout the workshop, you'll also participate in invaluable Interactive Exercises that will make you feel like you're engaged in an actual inspection, giving you priceless hands-on experience that will serve you well for years to come.
Identify the elements of and compose a central laboratory audit SOP … learn the 5 Key Tools for CQA Auditors: Preparation, Performance, Interviewing, Writing and Post-Assessment — and how to confidently employ them … and much, much more.
Finally, you'll walk away after two days with valuable tools you'll be able to put to use immediately:
- Slides from PowerPoint presentations
- Case review worksheets
- Interactive exercise worksheets
- SOPs, forms, templates for CQA audits: site, CRO and central laboratory
- Copies of applicable FDA/ICH regulations and guidances
Clear your calendar NOW for Risk-Based Clinical Quality Assurance: Train Your Auditors Like the FDA Does on June 18-19, 2014, in Bethesda, MD.