Clinical Quality Assurance Conference - Register Today
Further details & registration: http://www.fdanews.com/CQA [www.fdanews.com/CQA]
Learn how to FDA-proof your CQA audits -- eliminate costly mistakes -- and avoid FDA warning letters that say: "You failed to obtain and document that valid informed consent was obtained for each of the subjects enrolled in the study as required by stated regulations."
Clinical trial sponsors rely on clinical quality assurance (CQA) auditors to find vulnerabilities before noncompliance can shut down their studies. But with millions of dollars and decades of research at stake, study staffers are not always eager to cooperate.
That's why even the most experienced CQA auditors must apply the necessary tools and skills to the CQA function, including how to:
- Understand the basic principles of GCPs and international regulations
- Determine if GCPs are being followed and what needs to be documented
- Balance the relationships -- QA, clinical and the CRO -- in the ever-changing economy where clinical study outsourcing is common
- Define responsibilities with outsourced clinical trials and the role communication plays in maintaining compliance
- Select sites to be audited -- strategies for deciding who to audit
- Audit a CRO or central laboratory -- who and how do you audit these specialized providers
- Manage the audits (logistics, time, etc.) -- understanding the management of the audit is essential to assuring completion of everything that needs to be done
- Conduct the audits -- what do you do and what interviewing skills are needed
- Compose the site visit audit report - writing it is sometimes the hardest thing to accomplish
- Evaluate the audit findings and implement corrective actions -- once the report is written the audit is not over
- Master FDA inspections and avoid the top five GCP violations
WHO SHOULD REGISTER:
- Clinical quality assurance managers & auditors
- Clinical site directors
- Clinical research associates/coordinators
- Regulatory affairs
- IRB administrators
MEET YOUR INSTRUCTOR:
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 U.S. and Europe.
Ms. Sceppa has implemented and managed preclinical, clinical and manufacturing quality assurance programs for numerous clients and has knowledge in the details of compliance with all U.S. federal regulations. These include : 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, she has been a faculty member of the Parenteral Drug Association's (PDA) Training and Research Institute (PDA-TRI) in Baltimore MD.
Clinical Quality Assurance: Roles and Responsibilities for Auditors & Managers
Presented by MSceppa Consulting & FDAnews
Tue & Wed, Oct 23-24 2012 -- Boston MA USA
Revere Hotel Boston Common
200 Stuart St
Boston MA 02116
855-673-8373 toll free phone
Room rate: $269 plus 14.45% tax
Reservation cut-off date: Oct 1 2012
Tuition of $1,797 includes all workshop sessions, workshop written materials, two breakfasts, two luncheons and daily refreshments. Payment is required by the date of the conference. American Express, Visa and MasterCard are accepted. Make checks payable to FDAnews.
4 EASY WAYS TO REGISTER:
By phone: 888-838-5578 or 703-538-7600
Mail to: FDAnews, 300 N Washington St Ste 200 Falls Church VA USA 22046-3431
You must be entirely satisfied with this learning opportunity or FDAnews will refund your entire tuition, or extend a credit to a future FDAnews conference.
Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.