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ComplianceOnline Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step

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In this excel Spreadsheet validation full day webinar training, learn the best way to design and validate the excel spreadsheets. Learn what the requirements are of excel validation and how to implement it to comply with regulations.

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ComplianceOnline Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step

  1. 1. Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step October 26, Tuesday 10:00 AM EDT | 05:00 PM EDT Why Should You Attend: Excel spreadsheets used in regulated environments should be validated and comply with other FDA requirements. In this interactive one-day on-line seminar Dr. Ludwig Huber will give an introduction to FDA, GAMP® 5 and other require- ments for validation of excel sheet and present approaches for implementation. This is a comprehensive course cover- ing validation, design, testing of functions along with how to apply risk based validation techniques for spreadsheet application. Learn best practices of document planning, specifications, installation, testing and changes. Learning Objectives: • Understand regulatory requirements for validation and use of Excel spreadsheets. • Understand how to effectively design and develop Excel spreadsheets for compliance. • Learn how to effectively validate Excel spreadsheets. • Lean what and how to test for Excel spreadsheets. • Learn how to maintain spreadsheets in a validated state. • Learn how to document Excel spreadsheet validation for FDA and other regulations. Date: October 26, Tuesday 2010 Time: 10:00 AM EDT | 05:00 PM EDT Duration: 6 hrs Instructor: Dr. Ludwig Huber Location: Your office or conference room (no need to travel!) Dr. Ludwig Huber Register Now How It Works: This excel validation virtual event has 6 modules. Our speaker will deliver the modules using PowerPoint slides. Practical examples, case studies and exercises will be dispersed into and between the presentations. About 50% of the time will be dedicated to discussions and practical sessions. As an example, attendees will receive fill-in tem- plates to document validation steps from beginning to end, in other words, from validation planning and writing specifi- cations to testing and writing the validation report. Application examples will be generic and easy to understand. The results will be discussed and conclusions will be documented by the presenter and will be available for download from a special reference website. Attendees can use the templates to validate and document their own Excel applica- tions. At the end of each module participants can ask verbal questions through the audio line. Written questions can be submitted at any time.
  2. 2. Areas Covered in the Seminar: • Regulatory requirements for spreadsheets: Good Practice Regulations a 21 CFR Part 11. • Typical compliance problems with spreadsheets. • Recommendations from GAMP® 5. • Recommendations from FDA's two Information bulletins for: single users and multiple users of spreadsheet applications. • How to design spreadsheets for compliance and easy validation. • When, what and how much to test. • Testing of standard (native) Excel functions. • How to apply risk based validation to spreadsheet applications. • Validation of 'ad hoc' spreadsheet applications. • How to document planning, specifications, installation, testing and changes. • Examples from manufacturing, laboratories and offices. Detailed Agenda: Module 1. FDA and International Requirements and Enforcement (45 min) • FDA regulations for development, clinical testing, manufacturing and quality control laboratories • Examples of FDA 483's and Warning Letters • Regulated vs. non-regulated spreadsheet applications • International regulations and guidelines related t: EU GMPs, Annex 11, PIC/S • Recommendations from Industry guides: GAMP ® 5, IEEE' • Out of the Box' Excel deficiencies for compliance • ‘ Alternative solutions for compliance • Interactive discussion Module 2: Planning for Efficient Validation and Compliance (30min) • Developing a compliance and validation policy • Developing a master plan, SOPs and templates • Search for and documenting all spreadsheet Installations • Standardizing hardware, software, documentation • Train developers and users • Including spreadsheet applications in regular audits • Interactive discussion Module 3. Design of Excel Spreadsheets for Part11/GxP Compliance (45 min) • Design for error detection • Design with integrity in mind • Using MD5 checksums to document spreadsheet and data integrity • Design for authenticity • Design for spreadsheet and data security • Building audit trail into Excel spreadsheets • Interactive discussion
  3. 3. Module 4: Validation of Excel Spreadsheets - Step-by-Step (150 min) • Developing a project validation plan • Writing specifications • Testing during development and during installation • Testing of Excel standard/native functions yes/no? • Validation and documentation of VBA scripts • Writing the validation report • Interactive discussion Module 5: Maintaining the Spreadsheet in a Validated State (45 min) • Regular checks of spreadsheets • Training of new users • Maintain compliance during changes • Lear how FDA complies with their own regulation • Documentation for Part 11compliance • Interactive discussion Module 6. Putting it all together for different applications • Going though complete examples: from design to retirement • Interactive discussion Duration: (All in EST) 10.00-10.45 - FDA and International Requirements and Enforcement (45 min) 10.45-11.15 - Planning for Efficient Validation and Compliance (30 min) 11.15-12.00 - Design of Excel Spreadsheets for Part11/GxP Compliance (45 min) 12.00-01.00 - Validation of Excel Spreadsheets - Step-by-Step - Part ! (60 min) 01:00-02:00 - Lunch Break 02:00-03:30 - Validation of Excel Spreadsheets - Step-by-Step - Part II (90 min) 03:30-04.15 - Maintaining the Spreadsheet in a Validated State (45 min) 04.15-04:45 - Putting it all together for different applications (30 min) 04:45-05:00 - Wrap-up and final discussion
  4. 4. Hand-Outs: 10+ Reference Documents for Easy Implementation.This material will help attendees to quickly implement what they have learned in the seminars: • SOPs: • Validation of spreadsheet applications • Development and use of spreadsheets in regulated environments • Change control of software and computer systems • Checklist for Macros and Spreadsheet applications. • Examples. • A full set of validation examples from planning, writing specifications, and design to testing and reporting • Software and validation package: File integrity check with MD5 Hash Calculations. • FDA 483 form inspectional observations, establishment inspection reports and several warning letters with devia- tions related to Excel. Who Will Benefit: • All developers and users of spreadsheet applications in FDA regulated industries, e.g., pharmaceutical and device development, clinical trials, manufacturing and QC laboratories • Validation specialists • QA managers and personnel • IT professionals • Production and lab managers • Regulatory affairs • Training department • Documentation department • Consultants Instructor Profile: Ludwig Huber: Director and chief editor of www.labcompliance.com, the global on-line resource for valida- tion and compliance issues. Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences. Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment. Member of the FDA Spreadsheet Design and Validation Information Bulletin Review Team Registration Information: * Register Online. Use your American Express, Visa or MasterCard. * For more than one attendee get 20% off on the price of additional attendee. * Get your group to attend the webinar at a discounted price call +1- 650-620-3937. * Call +1 - 650-620-3937 or Fax your PO: 650-963-2556. * Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303. This message was sent to you by: ComplianceOnline www.complianceonline.com Copyright © 2010 ComplianceOnline.com 2600 E. Bayshore Road, Palo Alto, CA 94303

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