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.
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.