Falls Church, VA (PRWEB)
June 22, 2017
Clinical Quality Assurance:
Roles and Responsibilities for Auditors and Managers
**Presented by FDAnews and MSceppa Consulting **
Aug. 22-23, 2017 – Arlington, VA
Increased FDA scrutiny and growing demands to track and report adverse events place even greater pressure on aclinical quality assurance program. Get ready for tougher questions from FDA investigators and ensure that clinical trials meet the highest quality standards.
In two action-packed days, attendees will learn what FDA investigators use to evaluate sites.
This interactive workshop will teach attendees how to develop risk-based CQA processes and compliance readiness.
Attendees will 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.
She’ll walk attendees 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 this SOP is needed
- 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, attendees will also participate in invaluable Interactive Exercises that will make them feel like they’re engaged in an actual inspection, giving them priceless hands-on experience that will serve them well for years to come.
Finally, attendees will walk away after two days with…