
Achieving HIPAA-Compliant Workforce Training
Kate Borten, CISSP, CISM
60 Min
Product Id: 700215
This presentation gets to the real intent of the HIPAA training requirements and gives practical advice both for regulatory compliance and for boosting privacy and security program effectiveness. Many healthcare organizations subject to HIPAA federal regulations fall short in their privacy and security training programs today. But people are the weakest link when it comes to good security. Security professionals and NIST Special Publications agree that effective and repeated training is necessary for employees and other staff to consistently follow good privacy and security practices and behavior.

Update of Pharmaceutical law in the EU -Focus on Generic Opportunities & Biosimilars
Elizabethann Wright
60 Min
Product Id: 700195
Modifications in the EU law governing authorization of pharmaceutical products - The Cyprus clause, the new position of the innovative products and changes for the generic industry. The EU law governing authorization of pharmaceutical products has been substantially modified. The periods of market and data protection for innovative products have been clarified.

CAPA - Best Practices and Common Pitfalls for FDA Regulated Industries
Sue Jacobs
60 Min
Product Id: 700137
This CAPA session will discuss these common pitfalls and share best practices, strategies and techniques on how to deal with CAPA system in relation to Warning Letters and 483 citations. In 2005 greater than 50% of FDA Warning Letters and 483 citations were CAPA related.

Setting up a QSR Compliant CAPA System
Sue Jacobs
60 Min
Product Id: 700130
In this CAPA training learn how to utilizing multiple data sources to detect actual and potential nonconformities.

FDA's Expectations for cGMPs for Analyst/Process Chemists
Sandra N. Whetstone
60 Min
Product Id: 700205
Key areas that the FDA is likely to cover and what FDA’s expectations are This presentation will focus on those areas that the FDA is likely to cover and what FDA’s expectations are.

Process Validation and Process Controls: Radiation Sterilization
Lisa Foster
60 Min
Product Id: 700180
In this Sterilization training will review these requirements and practices for gamma and electron beam irradiation in a practical manner so the product manufacturer can better understand the application of the ANSI/AAMI/ISO 11137 and AAMI TIR 27.

Best Practices in Supplier Quality Management
Anil Gupta
60 Min
Product Id: 700151
This Supplier Quality Management training is targeted at intermediate-level quality managers who are looking to bring best practices discipline into their supplier quality management and environment. Supplier Quality Management is a critical business process for manufacturers who source components and parts from suppliers, whether the suppliers are just across the street or a continent away.

Basic HPLC Theory and Method Development
Jeff Phillips
60 Min
Product Id: 700194
This HPLC theory (high performance liquid chromatography) training will cover the beginnings of HPLC through method validation and method development. Attention will be paid to understanding the thought process behind HPLC theory methods in the laboratory.

Making cGMP Documentation Practical
Paula Shadle
60 Min
Product Id: 700179
This cGMP Documentation training will provide value to regulated companies required to follow strict documentation standards, whether GLP, GCP, or GMP.

Review of Changes to the New ANSI/AAMI/ISO 11137-2006 (Parts 1, 2, & 3) Sterilization of health care products - requirements for validation and routine control - Radiation Sterilization
Lisa Foster
60 Min
Product Id: 700174
This Radiation Sterilization training will review all the changes included in the new standard and how they will affect the device manufacturer.

Risk Management for Medical Devices: Best Practices to Make Your FMEA Process Work For You
Robert DiNitto
60 Min
Product Id: 700175
In this Medical device training will show you how to make the DFMEA process work for you. How to use the process to help focus your testing matrix to target the most critical aspects of the product's design and function.

IT Governance and Controls for FDA & SOX compliance: The single solution
James Robertson
60 Min
Product Id: 700188
How a common COBIT-based IT control solution can satisfy multiple regulatory and business requirements. This seminar will show you that a common IT control solution should be available to satisfy multiple regulatory and business requirements.

Service Providers and SAS 70 Reports Understanding Requirements, Compliance and Benefits
Alyssa Martin
60 Min
Product Id: 700189
This SAS 70 training will provide a Process of SAS 70 Audit, frequency & formatting of documenting controls in COSO and COBIT and SAS 70 Report types and impact of Sarbanes-Oxley to create the demand for SAS 70 audits.

Effective DOE Strategies to Streamline your Processes for FDA Regulated Environment
Jose Mora
60 Min
Product Id: 700165
This DOE (Design of experiments) training focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.

Validation of Analytical Methods and Procedures - Design, Conduct and Document for Efficiency and Compliance
Dr. Ludwig Huber
60 Min
Product Id: 700158
This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

Creating a Product Safety Program that is as Nimble as the New Product Development Program
Bryan Cole
60 Min
Product Id: 700183
This Product safety training examines how product safety can fit into a stage gate new product development process, and provides recommendations and examples on how to make product safety become an integral part of the new product development process

Implementing Clinical Trial Performance Metrics
Dr. Carla Hagelberg
60 Min
Product Id: 700182
This Clinical Trial training will helps in implementing Metrics that can be used as clinical trial performance improvement indicators.

Email: A Best-Practice Approach to Compliance
Alan Calder
60 Min
Product Id: 700142
This webinar is technology-agnostic and sector-neutral. It is aimed at anyone in organizations of any size and in any sector who is battling with the inexorable growth in email usage and storage.

Leveraging Technology to drive Best Practices in ERM (Enterprise Risk Management) and Compliance
Peter Teuten
60 Min
Product Id: 700146
The purpose of this ERM (Enterprise Risk Management) training is to provide a framework of features, benefits, underlying processes, and best practices required to select or build an effective and efficient risk and compliance management system.

10 Pre-SOX Tips for Smaller Public Companies
Bob Benoit
60 Min
Product Id: 700133
In this SOX compliance training emphasis will be placed on key controls and company level controls that significantly influence the control structure in smaller organizations.