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Part 11 - Electronic Records and Electronic Signatures
Betty Jones
60 Min
Product Id: 700619
This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
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Using the FDA guidance General Principles of Software Validation to strengthen your firm's software FDA compliance
Dennis Moore
60 Min
Product Id: 700443
This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.
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Risk Based Validation of Software and Computer Systems
Dr. Ludwig Huber
60 Min
Product Id: 700339
In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.
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Change Control for Computer Systems - strategies and tools for FDA compliance
Dr. Ludwig Huber
60 Min
Product Id: 700078
This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.
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Reducing the Cost of Creating Documents for FDA-Regulated Industries
Chris Whalley
60 Min
Product Id: 700126
This FDA compliance training will explain how to measure and reduce the FDA recordkeeping burden.
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Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Kenneth Christie
Product Id: 703635
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
David Nettleton
Product Id: 701583
Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.
How to Buy COTS Software, and Audit and Validate Vendors
David Nettleton
Product Id: 703820
This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.
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Key Factors to Develop an Effective CAPA System
Kim Huynh-Ba
Product Id: 703320
This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.
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Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data
Barry A Friedman
Product Id: 705452
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
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Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations
Kim Huynh-Ba
Product Id: 705081
This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.
The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications
David Nettleton
Product Id: 704734
This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
David Nettleton
Product Id: 704533
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).