Pharmaceutical Company Specific Records and Information Management Programs

Why Should You Attend:

Since pharmaceutical and biotech companies rely so heavily on their proprietary research and clinical development there is a tendency within organizations to focus on the management of their information which relates to the requirements of the patent offices and regulatory agencies. This often results in the distributed management of designated silos of documents and records each with separate protocols and requirements. The rest of the organizations information archives are often overlooked or left to the whims of each department.

No one can accurately predict the total scope of information that may be required to run a successful business effectively and efficiently. The memory of employees to fetch information that has become unexpectedly vital has become more difficult because most people remain with an organization less than 5 years.

This situation can be remedied by instituting a centralized records and information program that categorizes all the information in the enterprise and tracks their locations. This program overlays and supports the efforts of staff working with research and regulatory information. The next result is a large gain in costs and efficiencies as well as better compliance to legal and regulatory issues.

Learning Objectives:

• Records and information fundamentals
• Establishing legal and regulatory guidelines and references
• Organizing information to be more efficient
• Authenticating critical business information
• Processes for software assessment and implementation

Areas Covered in the Webinar:

• Creating a workable and effective records and information policy
• Establishing records and information management responsibilities
• Determining the locations of all information resources
• Tips for establishing retention schedules (examples for R&D, legal, finance, clinical and regulatory and other functions)
• How to set up a friendly audit system that improves compliance
• Planning long term archiving
• Content and records management software considerations and options

Who Will Benefit:

• QC
• QA
• Document control
• Record and information managers
• IT
• Legal
• Regulatory
• Finance
• Facilities
• EH&S
• Clinical development

Instructor Profile:

Dr. Charlie Sodano is an experienced, globally recognized information management professional. He 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.

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