|
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
Everyday
08.00 AM
http://https://worldcomplianceseminars.com/seminardetails/29
1225 225 First Street, NE, Washington, DC 20002
DC / U.S. Capitol Washington 20002
Report Abuse
|
|
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Description
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
GxP records generated by spreadsheet calculations are electronic records and should comply with FDA’s 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently there are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data.
This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this has resulted in spreadsheets being among the most under-documented systems used in GxP environments because:
• users regard them as part of the desktop
• the ease with which applications can be built without much training
• the data processing power that they can have
• lack of knowledge that spreadsheets need to be validated
• lack of knowledge on how to validate spreadsheets
Consequently, Spreadsheets have become “low hanging fruit” during FDA or other regulatory inspections and many warning letters have been issued.
Areas Covered
Part 11 / Annex 11 Computer Systems Validation (CSV) is be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets. It will address the following topics:
1. Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)
2. Risk Based Approach and Controls to Excel Spreadsheets (incl. Excel specific risks)
3. Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)
4. The FDA’s Perspective and Use of Spreadsheets
5. Examples of Typical Approaches for Excel Validation
6. How to tailor your risk based methodology to Excel to determine the level of validation required
7. 483s and Warning Letters for Excel and other Spreadsheets
8. Quiz: Test your understanding of Computer Systems Validation for Excel
Who will Benefit
• VP of IT
• Director of IT
• Quality Managers
• Project Managers (for CSV / IT)
• Validation Specialists
• Database Administrators
• System Administrators
• Directors / Senior Directors of Discovery
• Directors / Senior Directors of Development
• Directors / Senior Directors of Commercialization
• Document Managers
• Training Managers
• Regulators
Learning Objectives
This 2 Days Workshop is intended for professionals in the
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Angela Bazigos
CEO Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.
Seminar One Registration $1295| Special Group Discount Register for Four attendees $3995|
https://worldcomplianceseminars.com/seminardetails/29
|
conference manager
Phone: 844-267-7299
Email: subscribe (at) worldcomplianceseminars.com |
|
|
| Report Abuse |
|
|
| |
| |
|
| List your Event |
| | Similar Events | DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Location 1: Washington DC
Jun 28 - 29
Description
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including wides
Date Posted: 04-May-18
| DC / U.S. Capitol : 2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar
2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018
Location 1: Washington DC
Jun 28 - 29
Description
GxP records generated by spreadsheet calculations are electronic records and should comply with FDA’s 21 CF
Date Posted: 21-May-18
| FL: 2018 Update: How to Write Effective SOPs for FDA inspection
2018 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
Description
Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as
Date Posted: 27-Apr-18
| FL: Live Webinar New and Expected Guidances on Data Standards and Electron
Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
Description
Each FDA center has different guidelines and processes to follow in order to have a successful submission for the re
Date Posted: 30-Apr-18
| FL: Live Webinar New and Expected Guidances on Data Standards and Electron
Live Webinar New and Expected Guidances on Data Standards and Electronic Submissions for Drugs and Medical Products
Description
Each FDA center has different guidelines and processes to follow in order to have a successful submission for the re
Date Posted: 11-May-18
| FL: Live Webinar FDA Compliance and Mobile Applications
Description
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, tobacc
Date Posted: 26-Apr-18
| Houston: Current Regulatory and Compliance Trends in the Area of Consent Decree
DESCRIPTION
Topic Background:
Many Years Ago Schering Plough underwent the first Consent Decree.
Since, then many years elapsed and the term Consent Decree was foreign to many employees and employers and to Industry overall.
Over the last Sev
Date Posted: 18-Feb-16
| FL: 3-hrs Virtual Training 2018 Latest FDA thinking on deciding when
3-hrs Virtual Training 2018 Latest FDA thinking on deciding when to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance
Description
A premarket notification (510(k)) is required when a legally marketed device subject
Date Posted: 31-May-18
| FL: 3-hrs Webinar-Deciding When to Submit a 510(k) for a Change to an Exis
3-hrs Webinar-Deciding When to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance
Description
A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is about to be
Date Posted: 30-Apr-18
| FL: 3-hrs Webinar-Deciding When to Submit a 510(k)
3-hrs Webinar-Deciding When to Submit a 510(k) for a Change to an Existing Device – FDA’s Final Guidance
Description
A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is about to b
Date Posted: 11-May-18
| Boston: 2018 Data Integrity Seminar : FDA/EU Requirements and Implementation
2018 Data Integrity Seminar : FDA/EU Requirements and Implementation
Location 1: Boston,MA
Oct 11 - 12
Description
Data Integrity audits project a moving goal post. Issues that were top warning letter vote getters have made way for newer one
Date Posted: 04-May-18
| Brisbane CA: 2 Day Workshop: Writing & Managing Effective SOPs
2 Day Workshop: Writing & Managing Effective SOPs
Location 1: San Francisco, CA
Jul 19 - 20
Description
Perhaps if everything always executed as planned then we would not need procedures, but this is not the case in the real wor
Date Posted: 21-May-18
| 94005: 2 Day Workshop: Writing & Managing Effective SOPs
2 Day Workshop: Writing & Managing Effective SOPs
Location 1: San Francisco, CA
Jul 19 - 20
Description
Every biopharmaceutical company has SOPs, and new staff members are told that the company “has to have them” and that each emplo
Date Posted: 04-May-18
| Shoreline Court: 2 Day Workshop: Writing & Managing Effective SOPs
2 Day Workshop: Writing & Managing Effective SOPs
Location 1: San Francisco, CA
Jul 19 - 20
Description
Every biopharmaceutical company has SOPs, and new staff members are told that the company “has to have them” and that each employe
Date Posted: 17-May-18
| Houston: Hypothesis Testing for Means ? A Practical Approach
DESCRIPTION
One common statistical technique, especially useful in quality engineering and manufacturing, is the hypothesis test. While it is common, it can be confusing and not well understood. In addition, some instances can involve complicated
Date Posted: 18-Apr-16
|
|
Map locations are shown as per geocoding services and they depeneds on the accuracy of the address. If address is wrong it may show wrong map. If you put a listing which shows wrong map, please remove the listing and create a new one with correct address details.
Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks.
|
| Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks.
|
|
