WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness

webinar-speaker   Dr. Ludwig Huber

webinar-time   60 Min

Product Id: 700123

This FDA compliance training will guide attendees through the entire process from establishing trainings, through developing and implementing training plans to FDA compliant documentation of effectiveness.

Recording Available

* Per Attendee $99

 

Radiation Dose Setting - Method 1

webinar-speaker   Joyce Hansen

webinar-time   60 Min

Product Id: 700119

The steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method. This presentation is the first of three presentations on the methodologies for the determiniation of the minimum sterilization dose.

Recording Available

* Per Attendee $249

 

10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 700125

This Risk Analysis training will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report, as outlined in ISO 14971:2001, a standard recognized by the FDA and rapidly being adopted by industry.

Recording Available

* Per Attendee $249

 

Sarbanes-Oxley Risk Assessment for Pharma/Bio/Life Science Industries

webinar-speaker   Bob Benoit

webinar-time   60 Min

Product Id: 700122

This SOX compliance training will provide a uniquely effective road map to documenting and assessing risks at Pharma/Bio/Life Science companies.

Recording Available

* Per Attendee $249

 

Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation

webinar-speaker   Dr. Ludwig Huber

webinar-time   60 Min

Product Id: 700107

This OOS (out of specification) training will guide you through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.

Recording Available

* Per Attendee $249

 

A Review of Sarbanes-Oxley's Impact on IT in Year Three

webinar-speaker   George Spafford

webinar-time   60 Min

Product Id: 700111

This SOX compliance training will benefit public companies who are either embarking on their Sarbanes-Oxley compliance journey or are struggling with sustaining their current control environment.

Recording Available

* Per Attendee $249

 

Leveraging best-practice frameworks to simplify regulatory compliance

webinar-speaker   Alan Calder

webinar-time   60 Min

Product Id: 700102

This regulatory compliance training will help in frame working and Leveraging best-practices in the way of the business in a cost effective manner. Organizations face complex and rapidly evolving regulatory requirements, which have to be met within an equally fast-changing information threat environment.

Recording Available

* Per Attendee $249

 

Master Planning for Computer System Validation

webinar-speaker   Dr. Ludwig Huber

webinar-time   60 Min

Product Id: 700106

This Computer System Validation training will guide you through Master Planning process.

Recording Available

* Per Attendee $249

 

Understanding the ISO 9001:2000 Process Approach to Implementation

webinar-speaker   Brad Snyder

webinar-time   60 Min

Product Id: 700086

This Quality compliance training provides an understanding of the concepts, intent and the application of the process approach to the ISO standards. This webinar provides an understanding of the concepts, intent and the application of the "process approach" to the ISO 9000 family of Quality Management System standards.

Recording Available

* Per Attendee $199

 

GMP Raw Materials Program Risk Management

webinar-speaker   Paula Shadle

webinar-time   60 Min

Product Id: 700094

This GMP (Good Manufacturing Practice) training will discuss strategies to ensure that your resources are deployed to maximize risk reduction, sustain GMP compliance, and respond to exceptions appropriately. Raw materials used in GMP production must be qualified, sourced appropriately, and tested before release into use. Regulations regarding sampling and testing vary globally, creating business and compliance challenges.

Recording Available

* Per Attendee $249

 

Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance

webinar-speaker   Paula Shadle

webinar-time   60 Min

Product Id: 700088

In this Cleaning Validation training will discuss strategies that assure that cleaning validation is started at the optimal time of the product development cycle, current trends, and some of the challenges that must be addressed.

Recording Available

* Per Attendee $249

 

Change Control for Computer Systems - strategies and tools for FDA compliance

webinar-speaker   Dr. Ludwig Huber

webinar-time   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.

Recording Available

* Per Attendee $299

 

IT Controls: Identifying the Building Blocks for SOX Compliance

webinar-speaker   Anil Gupta

webinar-time  

Product Id: 700144

Identifying the building blocks to ensure that IT controls are totally integrated into the Sarbanes-Oxley compliance initiative. Financial reporting processes are driven by IT systems that are deeply embedded in initiating, authorizing, recording, processing and reporting of financial transactions.

Recording Available

* Per Attendee $249

 

Reducing the Cost of Creating Documents for FDA-Regulated Industries

webinar-speaker   Chris Whalley

webinar-time   60 Min

Product Id: 700126

This FDA compliance training will explain how to measure and reduce the FDA recordkeeping burden.

Recording Available

* Per Attendee $299

 

Reduce the cost of Sarbanes Oxley Compliance using Control Automation

webinar-speaker   Arthur Stewart

webinar-time   60 Min

Product Id: 700068

This Sarbanes Oxley Compliance (SOX) training is targeted at compliance and risk managers who are looking to leverage leading technology to increase quality and reduce the costs of compliance and process management.

Recording Available

* Per Attendee $199

 

 

ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

webinar-speaker   Mark Stevens

webinar-time   60 Min

Product Id: 700060

In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.

Recording Available

* Per Attendee $249

 

Microsoft Word and Excel in FDA Regulated Industries: Pack of Four Training Courses

webinar-speaker   Chris Whalley,Dr. Ludwig Huber

webinar-time   4 hrs

Product Id: 700263

Validation and use of Microsoft Excel Spreadsheets, Good documentation practices, Using Styles in Microsoft Word, Reducing the cost of creating documents. This pack of four training courses provides 4 hours of traning on validation and use of Microsoft Excel Spreadsheets, good documentation practices, using Styles in Microsoft Word, and reducing the cost of creating documents in FDA Regulated Industries.

Recording Available

* Per Attendee $399

 

FDA Compliant Marketing/Promotions for Medical Device Companies - Best Selling Package Webinar

webinar-speaker  

webinar-time  

Product Id: 701832

The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc.

Recording Available

 

Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 701487

This 90-minute webinar on laboratory OOS investigations will review the regulatory requirements for an OOS Investigation. You will learn common regulatory pitfalls and how to structure an Investigation report that satisfactorily documents the investigation.

Recording Available

 

 

 

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