
Best Practices on Six Sigma and CAPA Convergence
Jose Mora
60 Min
Product Id: 700168
This Quality compliance training will helps in methodologies of Six Sigma and CAPA converging and how to recognize which methodology is best to use for a problem.

cGMP System Strategies for Cost effective Compliance
Garry Bandel
60 Min
Product Id: 700167
This FDA compliance training offers pragmatic approach to dealing with FDA mandated quality systems. The approach offered emphasizes function over form. Anyone subject to 21 CFR Parts 210, 211 and 820 will benefit from this seminar.

Radiation Dose Setting - Method 2
Joyce Hansen
60 Min
Product Id: 700120
This Radiation dose training is the second of three presentations on the methodologies for the determination of the minimum sterilization dose.

Change Control - Implementation and Management
John E Lincoln
60 Min
Product Id: 700160
This Change Control training will helps in change control implementation and management to ensure that documentation reviewed years later correctly reflects how product was designed, produced, tested, and released years earlier.

Using Risk Analysis to Optimize Product Development and Manufacturing
Robert DiNitto
60 Min
Product Id: 700166
This Risk Analysis training guide you through the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs and step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application. Did you know that you can use your existing Risk Analyses to help you do more than manage risk? Risk Analyses can be used to prioritize and streamline Design Input, Design Output, Design V&V, and both Pre-Production.

Catching Up on Computer System Validation: Meeting FDA and ISO 13485: 2003 Requirements
Tim Stein
60 Min
Product Id: 700145
The FDA and ISO requirements for computer system validation and key methods for meeting those requirements. Many regulated companies are still using unvalidated computer systems. Computer system validation is required by the FDA as well as ISO 13485: 2003. Medical device companies must transition to the 2003 version of 13485:2003.

Auditing HIPAA Security Rule Compliance
Kate Borten, CISSP, CISM
60 Min
Product Id: 700124
This HIPPA compliance training will give Practical tips on how to perform compliance audit in a manner that will protect the organization from legal challenge while also furthering security protections for patient-identifiable data.

How to Prepare for an OSHA Inspection
Lourdes Menendez
60 Min
Product Id: 700105
This OSHA Inspection training will guide you through OSHA procedures when they visit a company and what they look for and the main rights and responsibilities employers have with respect to OSHA. This program introduces the basic way OSHA functions. Before you invest money in courses and isolated actions you need to know what OSHA expects from employers and how to comply with their basic requirements.

Improving the Quality of Pharmaceutical Product Safety Reporting through the use of Metrics
Dr. Carla Hagelberg
60 Min
Product Id: 700131
This Product Safety training will guide you on how metrics can be used to analyze and improve the process for product safety. To meet regulatory requirements and to protect public health, pharmaceutical and biotech companies must collect, review, report, and assess product safety information to the highest standards.

How to Design an Effective and Efficient ISO 9001:2000 Management Review Process
Michael A Mathe
60 Min
Product Id: 700138
This webinar will focus on integrating PDCA with management review’s general, input and output clause requirements leading towards the design of both an effective and efficient management review process. Management review is truly one of ISO’s key processes. It is the gateway to understanding and managing all of the inputs and outputs of an effective quality management system.

Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
Dr. Ludwig Huber
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.

Radiation Dose Setting - Method 1
Joyce Hansen
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.

10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
John E Lincoln
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.

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

Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation
Dr. Ludwig Huber
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.

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

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.