Spreadsheets in FDA Regulated Environments webinar by Compliance4all
- Start Date:
- Wednesday, 4 January, 2017
- End Date:
- Wednesday, 4 January, 2017 11:15am
- Health & Nutrition
Overview:Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Areas Covered in the Session: FDA and other agency's requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
Learning from FDA warning letters related to spreadsheets How to design spreadsheets for Part 11/GxP/Annex 11 compliance Validation during design, development, installation and on-going use When, what and how much to test? For Easy Implementation, Attendees Will Receive User Manual with Excel functions that help to comply with FDA requirements SOP: Validation of spreadsheet applications SOP: Development and use of spreadsheets in regulated environments Gap analysis/checklist for Macros and Spreadsheet applications Who Will Benefit: Pharmaceutical and medical device industry Contract laboratories All developers and users of spreadsheet applications Validation specialists Speaker Profile:Dr.
Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare".
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216