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The Trainer
Teri Stokes,
Consultant in Computer Validation, GXP International |
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| Who Will Benefit: |
- Clinical Research Associates (CRAs), monitors, and study planners in Contract Research Organizations (CROs) and the clinical operations departments of local pharmaceutical and biotech companies.
- Principle Investigators and Study Nurse and Nursing QA professionals in University Hospitals , Medical Institutes, and Physician Groups and Clinics who intend to provide clinical trial services to the global pharmaceutical and biotech industries.
- Suppliers of software and IT services to the GCP regulated marketplace.
- IT departments in these same organizations.
- Regulatory Affairs, Quality Assurance (QA) and Quality Control (QC) professionals in both medical and technology areas.
- Auditors and inspectors in the GCP regulated clinical trial process.
- Validation specialists and consultants.
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| Trainer Profile : |
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Teri Stokes,
Since 1996 Dr. Stokes has had a successful global consulting practice in computer validation as GXP International. This practice benefits from a background of 16+ years in the computer industry at Digital Equipment Corporation based in the USA and also in Switzerland as well as 12 years as a registered Medical Technologist working in hospital, university, and central medical laboratories. She has authored two books and many invited chapters and journal articles on the subject of common sense computer validation practices.
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Common Sense Computer Compliance Practices for Medical Sites and CROs Performing Clinical Trials
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on “Common Sense Computer Compliance Practices for Medical Sites and CROs Performing Clinical Trials” by Teri Stokes, Since 1996 Dr. Stokes has had a successful global consulting practice in computer validation as GXP International.
TIME |
ACTIVITY |
9:00 |
Interactive Tutorial: How to Assess Risk and Qualify Site Systems Identified as Subject to GCP/Part 11 Regulations |
10:00 |
Group Exercise: Apply GCP Risk Analysis & Validation Status Check Forms to own systems |
10:40 |
Break |
11:00 |
Facilitated Discussion: Implementation Issues for Electronic Data Capture (EDC) Systems Used in Clinical Trials Today – eCRF, IVRS, ePRO/diary |
12:00 |
Lunch |
1:00 |
Interactive Tutorial: The Electronic Data Quality Plan and Its Role in Managing Site Systems for a Compliant Clinical Trial |
2:00 |
Case Work Exercise: Preparing an Electronic Data Quality Plan for a Clinical Trial |
2:40 |
Break |
| 3:00 |
Case Work Exercise: Share Results of Case Work Exercise |
3:30 |
Interactive Tutorial: Preparing for and Hosting Medical Site Audits of Clinical Trials Using Computerized Systems |
4:30 |
Facilitated Discussion: Site Audit Experiences and Audit Log Role |
5:00 |
Wrap-up and adjourn |
| How do we identify those systems at our medical site that are subject to GCP/Part 11 regulations without being a computer person? |
| How do we perform a risk analysis and document the current status of GCP systems identified at our site for a specific clinical trial and across trials? |
| What is the most common electronic data capture (EDC) technology being used in clinical trials today? |
| What support should we get from a trial sponsor for any EDC technology they provide to our site for conducting a trial? (eCRF, IVRS, E-Diary, e-device) |
| How can we prepare an Electronic Data Quality Plan for a specific clinical trial at our site without being a computer person? |
| How can we prepare our local medical diagnostic and patient record systems for pharmaceutical company audits and inspection by authorities? |
| What do we do when the auditor or inspector comes to our site? |
PRICING:
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Price INR* |
Savings |
16th April to 30th April
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15,000 |
3,000 |
| 1st May to 15th May |
16,000 |
2,000 |
| 16th May to 31st May |
17,000 |
1,000 |
| Last Week |
18,000 |
0 |
* Price does not include taxes. 12.36% taxes will be included in final amount.
* 10% discount on group of 5 or more. |
Cancellation Policy
Requests for cancellations or date transfers need to be received at least Seven (7) business days prior to the event in order to receive a 25% refund. If a cancellation or reschedule request is received less than Seven (7) business days before the start date, the penalty of 100% of the cost will be applied. Refunds will not be allowed for "no-shows". If your plans should change, you may designate a substitute to attend in your place at any time. This cancellation policy is strictly enforced.
Cancellation Liability
CO reserves the right to cancel events for any reason at anytime. Cancellation liability is limited to the return of payment ONLY. CO will not reimburse registrants for any travel cancellation fees or penalties, including airfare and hotel. |
