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The Trainer
Teri Stokes,
Consultant in Computer Validation, GXP International |
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| Who Will Benefit: |
- IT professionals and auditors in local Contract Research Organizations (CROs) and local pharmaceutical and biotech companies who do vendor qualification for the purchase of GXP regulated systems and services.
- Suppliers of software and IT services to the GXP regulated marketplace of global pharmaceutical, biotech, and medical device companies.
- Regulatory Affairs, Quality Assurance (QA) and Quality Control (QC) professionals in both medical and technology areas.
- Auditors and inspectors of computerized data systems in the GCP/GLP/GMP regulated areas.
- 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 Validation Practices for Developing, Delivering, and Maintaining GCP Systems Used in Clinical Trials
As part of Global Compliance Series of seminars, ComplianceOnline brings you the expert view on "Common Sense Computer Validation Practices for Developing, Delivering, and Maintaining GCP Systems Used in 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: Defining Roles, Responsibilities, and Validation Packages across Operational Qualification (OQ), Installation Qualification (IQ), and Performance Qualification (PQ) |
10:00 |
Group Exercise: Compare and contrast examples of OQ, IQ, and PQ documentation taken from real projects – Verification & Validation Plans |
10:40 |
Break |
11:00 |
Interactive Tutorial: Quality Practices for the Software Development Life Cycle (SDLC) – Having the Process Generate the Documentation |
12:00 |
Lunch |
1:00 |
Interactive Tutorial: Quality Practices for System Installation, Data Center Management, and Electronic Archive of GCP Regulated Systems |
2:00 |
Case Work Exercise: Compare and contrast OQ, IQ, and PQ Test Plans. Read and discuss Business Continuity Plan and Incident Report Form |
2:40 |
Break |
| 3:00 |
Case Work Exercise: Share results of Case Work Exercise |
3:30 |
Interactive Tutorial: Hosting Practices for Audits and Inspections |
4:00 |
Facilitated Discussion: IT Audit Experiences and Audit Log Role |
5:00 |
Wrap-up and adjourn |
| Why are there three different types of validation packages? How do they compare with each other? Which one is relevant to our org anization? |
| How "GCP healthy" is our software development life cycle (SDLC) and why isn't ISO 9000 certification enough for the US FDA? |
| What do auditors and inspectors look for in an Operational Qualification (OQ) package coming from the SDLC process producing systems for regulated GCP environments? |
| What is the difference between an electronic archive and an escrow account and why are both needed? |
What are the industry standard quality practices for data centers and computer rooms that:
1) Support SDLC environments for developing software products to be sold into markets regulated by GCP, GLP, or GMP (GXP) regulations, e.g., global pharmaceutical, biotech, and medical device industries?
2) Host GXP data and software application systems? |
| What do auditors and inspectors look for in the IT department's Installation Qualification (IQ) package for GXP systems? |
| What is the difference between Business Continuity and Disaster Recovery Planning and why are both necessary? |
PRICING:
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Price INR* |
Savings |
16th April till 30th April
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15,000 |
3,000 |
| 1st May till 15th May |
16,000 |
2,000 |
| 16th May till 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. |
