Clinical Quality Assurance: Roles and Responsibilities for Auditors and Managers

Regular Price: $1,797.00
Early Bird Price: $1,597.00

Clinical Quality Assurance: Roles and Responsibilities for Auditors and Managers

An Interactive Workshop presented by FDAnews and MSceppa Consulting

April 10-11, 2018
Courtyard Boston Cambridge • Cambridge, MA

Register before March 11 and save $200!

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. Auditing veteran Michelle Sceppa walks you step by step through such details as:

  • A review of how the FDA conducts clinical inspections and the top five GCP violations
  • How to write GCP audit SOPs — what elements to include
  • Writing a central laboratory audit SOP and why you need to have one
  • 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 Clinical Quality Assurance on April 10-11, 2018, in Cambridge, MA.

Who Will Benefit

  • Clinical quality assurance managers and auditors
  • Clinical site directors
  • Clinical research associates/coordinators
  • Regulatory affairs
  • IRB administrators

PRESENTER

Michelle Sceppa, principal and founder of MSceppa Consulting has more than 25 years of experience in quality assurance and regulatory compliance in the pharmaceutical and medical device industries. As a lead auditor, she has conducted and managed more than 300 internal and external audits for drug, biologic and medical device firms in the US and Europe.

Ms. Sceppa has implemented and managed preclinical, clinical and manufacturing quality assurance programs for numerous clients and is knowledgeable in the details of compliance with all US federal regulations, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for drugs, biologics and medical devices.

Ms. Sceppa is also certified in the Q7A regulations for the manufacture of active pharmaceutical ingredients. Since 2002, Ms. Sceppa has been a faculty member of the Parenteral Drug Association’s (PDA) Training and Research Institute (PDA-TRI) in Baltimore, MD.

LOCATION

Courtyard Boston Cambridge
777 Memorial Drive
Cambridge, MA 02139
Toll Free: (888) 236-2427
+1 (617) 492-7777
Hotel Website

Room rate:
$248.00 plus 14.5% percent tax

Reservation cut-off date:
March 10, 2018