Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers.
In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S:
"The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..."
The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a product or process step; and to match the V&V process to the product and risk.
Why you should attend:
* Whether you're planning to audit an internal IT system, anticipating an audit from a customer, preparing for the inevitable FDA inspection, or a vendor wishing to clearly demonstrate a software product is Part 11 compliant, this teleconference will give both old hands and new staff the practical information needed to understand the applicable regulations and solid methods to document compliance.
* FDA inspectors are now being trained to evaluate software validation practices.
* Increasing use of automated manufacturing and quality systems means increased exposure.
* Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny.
* A third of recent warning letters included citations with respect to improper or ineffective validation.
* Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This presentation will review the validation planning process with particular emphasis on avoiding common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.
Areas Covered In the Seminar:
* Outline of FDA regulations as applied to software.
* Review of FDA software validation requirements.
* Why validation makes good business sense.
* Most Common Problems in FDA Software Validation & Verification.
* Strategies on how to avoid the most common problems.
* Advice on successful validation project staffing.
Who will benefit: The staff members who will benefit include:
* System owners - responsible for keeping individual systems in validation
* QA / QC managers, executives and personnel
* Validation specialists
* Software quality reviewers
* Consultants
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U.S:
"The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..."
The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited numerous companies on software verification and validation issues in Warning Letters and inspectional observations. The presentation will address some common sense approach to this dilemma without going overboard; such as having V&V plans and processes that clearly define the completion criteria for a product or process step; and to match the V&V process to the product and risk.
Why you should attend:
* Whether you're planning to audit an internal IT system, anticipating an audit from a customer, preparing for the inevitable FDA inspection, or a vendor wishing to clearly demonstrate a software product is Part 11 compliant, this teleconference will give both old hands and new staff the practical information needed to understand the applicable regulations and solid methods to document compliance.
* FDA inspectors are now being trained to evaluate software validation practices.
* Increasing use of automated manufacturing and quality systems means increased exposure.
* Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny.
* A third of recent warning letters included citations with respect to improper or ineffective validation.
* Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This presentation will review the validation planning process with particular emphasis on avoiding common pitfalls. The attendee should leave the presentation confident in their ability to improve the level of validation success.
Areas Covered In the Seminar:
* Outline of FDA regulations as applied to software.
* Review of FDA software validation requirements.
* Why validation makes good business sense.
* Most Common Problems in FDA Software Validation & Verification.
* Strategies on how to avoid the most common problems.
* Advice on successful validation project staffing.
Who will benefit: The staff members who will benefit include:
* System owners - responsible for keeping individual systems in validation
* QA / QC managers, executives and personnel
* Validation specialists
* Software quality reviewers
* Consultants
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
