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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.