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LATEST NEWS
Wednesday March 10, 2010
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EMEA-FDA GCP Initiative
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FDA IRB Registration Rule
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Study data may be fake.
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Biosearch Moniotring Information System (BMIS) File.
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New Release -International Compilation of Human Research Protections 2009 Edition
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New FDA Draft Guidance document issued: Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting - Improving Human Subject Protection
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FDA Revises Clinical Investigator Compliance Program CP 7348.811
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FDA Bars Doctors from Drug Trials.
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OHRP Spanish Pamphlet Now Available
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The Clinical Research Quality Assurance Expert's Expert Sourcesm
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Training Managers
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Are you responsible for:- Getting high quality training that fits within your budget?
- Finding expert trainers who are also experts in Good Clinical Practice procedures?
- Locating Advanced Good Clinical Practice training programs for experienced monitors?
We have what you need! Our course attendees consistently cite, "excellent real life examples" as one of the most valuable aspects of the QRTI courses.
We work with you, the Training Manager, to meet your training objectives. We create custom programs covering the topics you decide are important to your corporate goals. We have the experience to deliver timely, directed programs that are fully interactive with practical application workshops providing "real world" experience. Attendees gain valuable tools for meeting their toughest questions. QRTI training attendees consistently rate our programs as the best they have attended in years since QRTI provided practical tools and solutions to their problems! .
QRTI provides effective training programs tailored to your company's needs and budget. Every QRTI trainer is a GCP expert with over 25 years of GCP field experience. We can customize training programs to meet your needs for your entry level or the most seasoned CRA. We work with you to create programs that address the issues your company is currently and will be facing. We work with you to develop presentations tailored to the attendee's level of expertise.
QRTI trainers address the most difficult issues and questions that your senior CRAs are asking.
Now there is training available for everyone...not just the same basic courses offered publicly but intensive, strategically targeted, high level courses for the best of the best.
Your CQA auditors and managers can finally attend a program that will address their challenges in assessing and managing clinical research. We can answer their toughest questions because we have years of hard clinical and quality assurance experience. QRTI trainers have trained and consulted for numerous companies from the small startup to the largest pharmaceutical, biotechnology and medical device firms.
Call us today! Let us put our experience to work for you! Let us make your employees GCP experts! Let us make you the expert in obtaining the best value for your budget dollars!
Here is a sample of our In-house Courses
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| In-house Workshops |
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| Inspection Readiness Interactive In-house Workshop |
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| This "course" is an interactive workshop. The objective is to prepare the attendees for an FDA/government inspection. The attendees all participate in a mock inspection and using in-house investigator files,(or study database for Data Management participants, or regulatory files for Regulatory folks), determine how to answer the inspector's questions. It is not a typical sit and listen course. The attendees will have to work together with the files to find their answers that will be discussed on Day 2. The mock inspection will follow the FDA Sponsor Inspection Program. Participants will learn by being placed in a role of responding to the inspector. Of course, learning by doing means that it will be very interactive with lots of opportunity to ask questions and to "try out" responses. |
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| Overview of the Inspection Readiness In-house Workshop |
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The objective of this course is to prepare project team members for FDA inspection at the sponsor facility. The course uses actual questions and requests for information that FDA uses during their inspections. Attendees are expected to obtain the information from their project files during the workshop period and return to the class prepared for the inspector's questions. This exercise allows the attendees to identify gaps in record keeping while the study is ongoing so that the gaps can be closed before the study is closed. It allows the attendees the opportunity to become familiar with the FDA's process of reviewing documents at the sponsor and gives the opportunity to role-play answers to FDA questions.
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The attendees should be anyone who may have to participate in a sponsor inspection including CRAs, GCP Auditors, Project Leaders, Clinical Managers, Medical Monitors, Pharmacovigilance personnel, and managers in Data Management. Attendees will group by project team to prepare responses and determine who on the team will be the spokesperson for each aspect of inspection.
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If regional CRAs attend, they should bring a copy of a monitoring file for their project, as they will be required to review monitoring reports as one of the workshop activities. In addition, they should identify an individual back in their regional office who can retrieve other information that they may need to answer the inspector's questions.
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It would be helpful for regional personnel to review the FDA Compliance Program CP7348.810 Part III, Sponsors, Monitors, CROs. http://www.fda.gov/ora/compliance_ref/bimo/7348_810/default.htm in advance. This program details all of the documents that FDA will request during inspection. It is not suggested that attendees bring all of these documents. During the workshop, we are trying to simulate a real inspection and we want to identify areas which would need more response time so that during a real inspection, the company will know which items cannot be retrieved immediately for the inspector.*
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| *It is expected that attendee will not have all requested documents available during the course and this is part of the process to be learned. |
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| AGENDA |
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| Day One |
| 8:30 |
am |
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9:00 |
am |
Continental Breakfast |
| 9:00 |
am |
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9:15 |
am |
Introduction |
| 9:15 |
am |
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10:00 |
am |
Overview of the Mock Inspection Process |
| 10:00 |
am |
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10:15 |
am |
Break |
| 10:15 |
am |
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11:30 |
am |
FDA Inspection Program CP7348.810 |
| 11:30 |
am |
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12:00 |
pm |
Workshop - Explanation |
| 12:00 |
pm |
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1:00 |
pm |
Lunch |
| 1:00 |
pm |
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1:30 |
pm |
Workshop - Form Teams and Determine Responsibilities |
| 1:30 |
pm |
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3:00 |
pm |
Workshop - Finding Answers for FDA Inspection |
| 3:00 |
pm |
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3:30 |
pm |
Workshop - Update - Issues & Concerns of Teams |
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Distribute example of FDA 483 - List of Observations |
| 3:30 |
pm |
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4:30 |
pm |
Workshop continues |
| 4:30 |
pm |
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5:00 |
pm |
Questions & Answers |
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| Day Two |
| 8:00 |
am |
- |
9:00 |
am |
Continental Breakfast |
| 9:00 |
am |
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9:30 |
am |
Teams meet and prepare for Inspector's questions |
| 9:30 |
am |
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10:30 |
am |
Inspector questions teams |
| 10:30 |
am |
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10:45 |
am |
Break |
| 10:45 |
am |
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12:00 |
pm |
Inspection continues |
| 12:00 |
pm |
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12:30 |
pm |
Workshop wrap-up |
| 12:30 |
pm |
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1:30 |
pm |
Lunch |
| 1:30 |
pm |
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2:30 |
pm |
Q & A |
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