Take advantage of our $1507.50 price by registering early!
* After Friday, May 28, 2021, costs are $1687.50.
workshop teaches practical, immediately usable techniques that top-notch Good
Clinical Practice (GCP) auditors and FDA investigators employ. They include
techniques that are useful when auditing clinical trials that employ Electronic
Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and
auditors apply these techniques, they can better detect, correct, and prevent
clinical study performance deficiencies at clinical sites and within their
organizations. Significant updates to
the seminar focus on the development and utilization of Quality Systems (QS) at
clinical sites to improve their performance. The workshop will emphasize Simple
Efficient & Effective QS processes that clinical site personnel can utilize
and how monitors and auditors can help them develop and implement them.
- Apply auditing standards based in current law,
regulations, and guidelines
- Utilize electronic systems to enhance your auditing techniques, allowing more efficiency in your daily monitoring or auditing activities
- Understand the role of quality systems in GCP, including techniques for detecting root causes of performance deficiencies and developing and implementing effective Corrective and Preventive Action (CAPA)
- Select investigators and records for
auditing or special monitoring emphasis
- Conduct clinical investigator audits
- Detect, prove, and prevent
scientific fraud and misconduct
- Learn techniques for writing audit plans and reports
- Clinical Quality Assurance Professionals who
audit the quality of clinical trials
- Clinical Research Associates and
Managers, Project Leaders, and Medical Monitors who want to enhance their
- Regulatory Affairs Professionals
responsible for GCP regulatory compliance
- Investigators, Study Coordinators
and Trial Center Managers who want to learn how to prepare for FDA and
sponsor audits and to improve the quality of their research activities
The course will be led by one of the following
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer
Day One: 8:30 a.m. – 5:00 p.m.
- The Standards: Important aspects of GCP-related
law and regulations: Food, Drug, and Cosmetic Act, Title 18 Criminal
Statutes, HIPAA, 21CFR 11, 50, 54, 56, 312, and 812; Corporate standards
- Trial Center Auditing Methods: Selecting centers to audit, auditing and inspection procedures
and methodology, including special procedures for “e-trials”; differences between
auditing and monitoring; Defining and determining the adequacy of source documentation;
developing and implementing Simple, Effective, and Efficient Quality Systems
to improve clinical site performance
- Fraud and Misconduct: Motives; discovering, reporting, and preventing fraud and
misconduct, including special techniques for e-trials
Two: 8:30 a.m. – 5:00 p.m.
- Data Trend Analysis: Definition and description of this special auditing
technique; multiple examples; how to practically use this technique;
Special subsection on detecting the signs and symptoms of impeding failure
at a trial center
- Auditing Techniques Exercise: Perform data trend analysis; audit to determine document
validity and data accuracy; perform root cause analysis; build a CAPA;
work individually and within a group of your peers
- Essential Documents: Define and prioritize; auditing the essential document
binder or files; the legal and regulatory basis behind the EDs
- Enforcers and Enforcement: The compliance organizations in CDER, CBER and CDRH; FDA
inspection results and consequences of adverse findings; how to manage a
regulatory authority inspection; FDA’s Application Integrity Policy
- Summary of Auditing and QS Processes: Audit Planning, Notifications, Conduct, Reporting; Root
Cause Analysis; developing and implementing CAPAs
- Perform Data Trend Analysis
- Accomplish an Audit of Source
Documents and CRFs
- Work on an Audit Team to Discuss and
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 15 hours (1.5 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-19-001-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1