How to Transition from Paper to Electronic Records in a Regulatory Environment
Instructor:
Charlie Sodano
Product ID: 703576
- Duration: 75 Min
Why Should You Attend:
The tendency, after a drug fails in clinical trials, is to retain all related information permanently. There are vast stores of pre-clinical, clinical and drug safety paper records that are archived in many companies for drugs that failed to reach the marketing stage for a variety of reasons.
- How do you efficiently manage this daunting task of converting all legacy paper records to an useful format?
- How do you effectively organize this archived data in an orderly manner so that information is not lost or difficult to locate?
This webinar will discuss proven and practical strategies to optimize the storage and organization of legacy information, paper as well as electronic. The speaker will highlight effective methods to index and organize records and integrate them so that it is easy to retrieve information. A transition from paper to electronic records will involve a myriad of challenging and complex decisions that are to be made. Attending this webinar will equip you with the necessary information and know-how to ensure that you make the right decisions.
Areas Covered in the Webinar:
- Records policy and procedures
- Records data map
- Incorporating paper records into a eCTD
- Converting paper documents into a useful electronic format
- Scanning costs and resources
- Indexing and organizing scanned records and integrating them
- Long term record storage and retrieval
- Big data – implications to the drug business
Who Will Benefit:
This webinar will benefit the following personnel from pharmaceutical and clinical trial companies:
- Research & Development
- Scientists
- Regulatory Affairs
- Clinical Research (project managers, investigators, study coordinators, operations, QA and document managers)
- Legal
- Information Technology
- Validation
- Documentation
Charlie Sodano
Founder, eOrganizedWorld
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, 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.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
