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Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Angela Bazigos

21 CFR Part 11 Compliance for Excel Spreadsheets

Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections.

Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Angela Bazigos

21 CFR Part 11 Compliance for Excel Spreadsheets

Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Angela Bazigos

How to Select Software for a Regulated Environment

Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?

Angela Bazigos

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance.

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections.

Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Angela Bazigos

FDA's 21 CFR 11 Add-On Inspections - Recent Updates

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings.

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