Auditing Clinical Studies for Good Clinical Practices (A002)

A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP

REGISTER

To Register On-line: select the course date below, then click on Pay Now (securely processed by PayPal
To Register by FAX: download form (PDF)

Locations to choose from:

All-Inclusive, CRUISE with 2days training and
Beach RESORT in Fort Lauderdale, Florida

Tel: +954-957-3957;
Fax: +954-366-6011;

E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Early registration for the RESORT is $975 +tax, if paid in full 30 days or more before the start, after that is $1250 + tax.
Early registration for the CRUISE is $1350 +tax, if paid in full 75 days or more before the start, after that is $1550 + tax.

To Register On-line:

Click on the arow below, select the course date, and then click on Pay Now (securely processed by PayPal)

Course Overview:

Clinical research is a highly regulated activity, and as such, the stakeholders (clinical investigators, sponsors and institutional review boards) are subject to regular inspections from regulatory authorities. The FDA under the Bioresearch Monitoring Program inspects investigators sites, sponsors and institutional review boards on a regular basis, and findings are posted though warning letters.

The pharmaceutical, biotech and medical device industry is highly regulated and clinical investigation has to comply with strict guidelines to ensure the protection of human subjects and the integrity of data. Clinical trials gather valuable data about the safety and efficacy of new compounds or devices. Audits focus on the processes concerning data acquisition, collection, transcription and analysis. Those audits or inspections have the purpose to verify compliance with GCP and country specific regulations. The FDA also conducts inspections outside the US (e.g. Canada, EU) to verify that data generated in the audited country complies with FDA regulations for US submissions.

The purpose of this workshop is to introduce clinical and regulatory personnel to the audit process and how to handle of the outcome trough guided responses to Inspectional observations – 483’s and Warning letters.

Course Outline

Preparation for an audit	Internal audit vs. Regulatory audit
Who should be informed at the site of the GCP/FDA audit	Results from an audit
Pre-FDA inspection	How to write an internal audit report, the audit certificate
Audit procedures (SOPs for internal audits)	Analysis and interpretation of an audit report
FDA/HPFBI GCP audit procedures and regulations	Dealing with audit findings and corrective measures
Auditing Clinical Investigator Site	Compliance / non compliance
Auditing Trial Master Files, Auditing the Sponsor	Repercussions of a notice of non-compliance
Auditable documents	FDA audit reporting, and consequences of violative findings

Who Should Attend

This two-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Medical Devices and allied industries with daily responsibilities in the following areas:

Clinical Research	Product Development
Consultants	Project Management
Documentation and Medical Writing	Quality Assurance
Others who interact together to launch a product	Regulatory Affairs
Product Submission	Training

CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL

Upon Completion of the course:

***CME: 12 Elective credits by the American Academy of Family Physicians will be available to qualifying participants and
All participants will receive a Certificate of Attendance
Also, after completion of the course, participant may decide to take a comprehension exam. If the exam is passed successfully, participant will receive the Certificate of Completion.

Registration fee for the RESORT includes:

2 whole days of training in a beautiful ocean-front hotel,steps to popular Las Olas Beach, in Fort Lauderdale, Florida
Presentation, Reference and Study Materials( printed, also electronic copy)
Breakfast, Luncheon and Refreshments

Registration fee for the CRUISE includes:

2 whole days of training on a luxury Friday to Monday All-Inclusive CRUISE
Presentation, Reference and Study Materials( printed, also electronic copy)
All meals and Refreshments

Each participant will receive a copy of the book:

"Good Clinical Practice (GCP) Audit Preparation: A Guide for the Pharmaceutical Industry", by: dr Mihajlovic- Madzarevic, Vera (to be published in April 2010 - ISBN: 9780470248850-Wiley)

Not Included

Airfare

Transportation to/from the airport

Parking, tips...

**Hotel accomodation: (Pelican Beach resort is completely non-smoking)

To reserve your room, call Amanda Mohler at Direct - 954.556-7560, Hotel-954.568.9431 or (800) 525-OCEAN and mention the "Clinical Research Institute of America's" special rate for the room (valid up to 1 month before course starts). You may also want to send an e-mail to: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Tax is not included, please add 6% to the price of the course.

Special group rates for this course (% off the regular price of the course):

From 1-2 people from the same facility/clinic - as advertised
From 3 and up to 5 - 10% discount for the entire group
From 6 and up to 10 - 15% discount for the entire group
More than 10 people per group - please call Vesna at 1-877-428-1427

Upon registration, you will receive a complete agenda and detailed information.

At the time of registration, please notify us of any special dietary requirements.

Enrolment to the course is accepted until one (1) week before the starting date.

Clinical Research Institute of America reserves the right to cancel the course, if insufficient number of students are enrolled.

For more information please Contact Us at:

Phone: 1-877-428-1427 (toll free USA & Canada) or +954-975-0860 Fax: 954-366-6011

E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

*CANCELLATION POLICY (% fee is based on a regular price of the course)

Cancellation from date of signing up to 30 days prior to event...........full refund

Cancellation from 30 days to 20 days prior to event.............................10% fee

Cancellation from 20 days to 10 days prior to event….. ……............. 20% fee, after that......... 30% fee

Note: Tax is not included - please add 6% to the price of the course.

PRIVACY POLICY

Any of the information we collect from you, in this form, will be used solely for the purpose of registering for this course. We do not sell, trade or otherwise transfer to outside parties any part of your personal information.

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