Using Excel Spreadsheets in FDA Regulated Environment

MessageThis Webinar is over
Date Oct 1, 2014
Time 12:00 PM EDT
Cost $235.00
Excel spreadsheets are easy and convenient to use for handling common data capture and analysis functions. FDA accepts data in Excel spreadsheets provided it meets the criteria of confidentiality and integrity defined within 21 CFR Part 11, GAMP 5 and related regulations. Excel can be made FDA compliant with simple procedures and practices to meet regulatory requirements. This seminar provide insight into regulatory requirements and inherent limitations in “Out of the Box” Excel, validation techniques, documentation requirements, and risk-based evaluation of Excel spreadsheets. Practical strategies and case studies will be used to highlight common issues and potential solutions.
Why Should you Attend:
Capability to use Excel creates an inexpensive and handy tool for FDA regulated industry, particularly R&D operations and early stage development activities. However, companies frequently struggle with understanding and implementing applicable regulations on spreadsheets. Many companies use invalidated spreadsheets leading to negative audit findings. This seminar will address all these issues by providing methods for planning and executing spreadsheet validations that satisfy FDA requirements.

Objectives of the Presentation:
  • Regulatory requirements for spreadsheets
  • Spreadsheet design considerations and validation methods
  • Risk based evaluation and qualification of spreadsheets
  • Documentation requirements
  • Common FDA audit findings and solutions
Who can Benefit:
  • System owners and personnel who create or use spreadsheets in FDA regulated areas
  • QA / QC managers, executives and personnel
  • IT / IS managers and personnel
  • Validation specialists
  • Software quality reviewers
  • Regulatory affairs and training personnel
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.

Instructor Profile:

Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993

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