
Leveraging best-practice frameworks to simplify regulatory compliance
Alan Calder
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.

Master Planning for Computer System Validation
Dr. Ludwig Huber
60 Min
Product Id: 700106
This Computer System Validation training will guide you through Master Planning process.

Understanding the ISO 9001:2000 Process Approach to Implementation
Brad Snyder
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.

GMP Raw Materials Program Risk Management
Paula Shadle
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.

Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance
Paula Shadle
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.

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.

IT Controls: Identifying the Building Blocks for SOX Compliance
Anil Gupta
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.

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.

Reduce the cost of Sarbanes Oxley Compliance using Control Automation
Arthur Stewart
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.

Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Tim Stein
60 Min
Product Id: 700063

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

Microsoft Word and Excel in FDA Regulated Industries: Pack of Four Training Courses
Chris Whalley,Dr. Ludwig Huber
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.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Computer Software Assurance: Use industry standards to be efficient and compliant
David Nettleton
Product Id: 707008
This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates.

UK RoHS and REACH: Post Brexit Obligations and Changes in 2024
Kelly Eisenhardt
Product Id: 706679
This 1-hour webinar will provide high-level overview of the UK RoHS and REACH obligations effective January 1, 2024 due to Brexit. Key developments and dates will be discussed with an emphasis on the new regulations and systems implemented by the UK.

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

Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)
Nanda Subbarao
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.
Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
David Nettleton
Product Id: 701584
Get a detailed understanding of how to perform risk assessment as part of the 10-step risk based approach to CSV.

Master Verification and Validation Planning to Meet Tougher U.S. FDA Requirements
John E Lincoln
Product Id: 701506
This V & V planning Webinar/ training will discuss how to companies can re-evaluate their V & V system and related documentation to get to a compliant and new systems and procedures.

Impact of Recent Immigration Developments on Employers
Sameer Khedekar
Product Id: 705344
Recent changes impact not only the employment of foreign nationals, but the broader workforce comprised of green card holders and international travelers. Executive leadership is looking to compliance officers, legal departments and human resources to understand how these changes affect their company. Tune in to learn how to ensure your business is not adversely affected by changes in immigration legislation and policy.