Webinar on Strategies to Preserve Records with Retention Schedules of More Than 10 Years" from GlobalCompliancePanel
Retention of records pertaining to drugs is a major issue in the drug industry. There is a lot of debate, discussion and even confusion on the period of time for which records need to be kept.
- Fresno, CA (1888PressRelease) January 16, 2013 - This webinar is about retention of records in the drug industry.
If records are to be kept permanently, what is the meaning of 'permanent'? Is it for the lifetime of the drug, the patent, the process, the organization, or that of the employee who created the record? If records are to be kept for a stipulated period of time, what happens when someone wants to access them after this time frame?
Another source of concern is about the nature of these records. If it is paper records; they need to be properly catalogued and indexed. They also need to be stored in a safe environment, and appropriate disaster recovery plans need to be put in place. As for electronic records; the challenge is greater. Every time technology gets upgraded; these records need to be changed accordingly. A delay in implementation of technology will result in either loss critical records or escalation of costs.
These and other related issues and requirements have been stated in various standards and statutes such as GLP, GMP, GCP and well as IND, NDA and BLA; but there is still a lot of ambiguity on a number of crunch areas. Addressing these is the core of this webinar session. It will explain how record requirements under GLP, GMP, GCP, and IND, NDA and BLA are connected to business needs. This session will cover the following areas:
o Records Management Fundamentals
o Regulatory record retention guidelines
o Disaster recovery strategies
o Long term record preservation strategies for paper and electronic records
When:January 16, 2013 10:00 AM PDT | 01:00 PM EDT
By whom:Dr. Charlie Sodano, Founder of eOrganizedWorld, a consulting firm that specializes in the planning and implementation of records and information management systems. It is a firm that consists of information management consultants for pharmaceutical, chemical and food R&D, and specializes in electronic records and information management systems implementations and Electronic Laboratory Notebooks.
Dr. Sodano began his career as a discovery research chemist at Pfizer and since 1985 has specialized in the management of electronic as well as paper based records and information. He managed Information Services departments at RJR Nabisco, Berlex Biosciences and Bayer HealthCare Pharmaceuticals and holds BS and MS and Ph.D. degrees in Chemistry.
In December, 2007 he launched eOrganizedWorld a consulting firm specializing in the planning and implementation of records and information management systems.
For whom:
The webinar will benefit professionals in
o Research & Development
o QA
o Regulatory
o Clinical Operations
o Manufacturing
o Records Management
o Legal
o Information Technology
Duration: 60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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