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.
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.