RAPS pre-approved webinar on "Implementing GAMP 5 in your Projects" from GlobalCompliancePanel
Good Automated Manufacturing Process (GAMP) 5 is a set of five important principles of automated manufacturing processes in the field of Life Sciences. Since it provides practical industry guidance on how to achieve compliant systems fit for intended use; it is considered the "how to" of a validated system in this industry.
- Fresno, CA (1888PressRelease) February 15, 2013 - Description:
GAMP 5 touches upon the important principles behind major industry-related developments and documents such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. By using a risk-based approach to validation that includes GAMP 5; pharmaceutical and life sciences companies have been able to bring down their validation costs without compromising on patient safety and product quality.
This webinar is about how to implement GAMP 5 into a validated system.This webinar focuses on the role of project team members in ensuring that projects are executed to satisfy scrutiny by regulators.After a walkthrough of regulations for good documentation practices, this webinar will transition to a brief explanation of validation enablers as enumerated in ISPE's GAMP 5Guide, which includes the V-model, ASTM's E-2500 standards. This session will also address the establishment of project controls, procedures and deliverables. It will finally discuss the validation deliverables that are most likely to be audited by regulatory agencies, along with their common errors for which they are cited.
Areas Covered in the Session:
- Understanding key validation regulations
- The 5 key principles of GAMP
- The V-model and ASTM E2500 model
- GAMP 5 documentation hierarchy
- Best practices for validation test execution and documentation using GAMP
- FDA 483 and Warning letters regarding Validation
When:February 15, 2013, 10:00 AM PDT | 01:00 PM EDT
By whom:
Chinmoy Roy is a Life Sciences expert with some 35 years of experience behind him. During these years, he has directed; implemented and validated industry-compliant computerized and control systems for pharmaceutical and biotech manufacturing and helping these firms obtain "fit for use" certification. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11.
His core expertise lies in coming up with lean integrated manufacturing solutions that include Quality by Design (QbD) and Quality Risk Management (QRM).
He has facilitated QRM sessions for large US companies and has provided them with supervision and expertise needed to establish their Quality Risk Management plans.
For whom:
The webinar will benefit
- Project Managers, Lead Engineers, Automation Engineers
- Documentation Managers, Document System Control Personnel
- Contractor, Consultants
- QA, Regulatory Affairs, R&D
- Manufacturing, Engineering & IT personnel
Duration: 60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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