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New SEC Guidance on Sarbanes-Oxley Section 404
Bob Benoit
60 Min
Product Id: 700538
This Sarbanes-Oxley Section 404 compliance training will discussed recent developments in the SEC guidance.
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Experiences of managing a quality management system for a virtual pharmaceutical company
Simon Forster
60 Min
Product Id: 700256
This quality management system webinar will discuss the advantages and disadvantages of the virtual models and useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities.
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FDA Inspections-Dos & Don'ts
Ashish Talati
60 Min
Product Id: 700163
It will provide an overview of the FDA inspection process in general along with a background and understanding of the role played by the Agency, its administrative and enforcement powers Pharmaceutical, biotech, medical device and generic drug companies will be most interested in attending this program. The seminar teaches important tips on how to prepare for and handle FDA and related regulatory inspections.
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Risk Communication of Medical Device Failures
Marta L Villarraga
60 Min
Product Id: 700450
This Risk communication webinar/training will review the types of risk communications that take place regarding medical device failures at both pre- and post-marketing stages in the lifecycle of medical devices.
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How to Audit Contingency and Business Continuity Plans
Javier Kuong
60 Min
Product Id: 700484
In this Audit webinar/training learn how to Audit Contingency and Business Continuity Plans and need for an effective audit of your contingency and business continuity plans. Having a contingency and business continuity plan is only half of the battle. A key issue is how does your organization know that the contingency and business continuity plan is sound and adequate for your needs? .
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Risk Management Activities during Design Input
Edwin L Bills
60 Min
Product Id: 700526
Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation. Risk Management Activities can lead to reduced cost and reduced time to market when conducted during the Design Input phase of product development. Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.
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Understanding EEO and Affirmative Action
Jarik E Conrad
60 Min
Product Id: 700542
This HR compliance training will provide participants with and understanding of the law as it relates to Equal Employment Opportunity and things that can be done beyond compliance to promote diversity in their organizations.
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HR Investigations: Body Language Do you Speak It?
Matthew W Burr
60 Min
Product Id: 700429
This HR Investigations training will be an invaluable resource to HR Professionals and Managers wanting to develop their skill observing human behavior during important conversations.
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Designing Viral Clearance Studies for Biopharmaceuticals
Kathryn Martin Remington
60 Min
Product Id: 700220
This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.
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Internal Controls and Governance: Strategies and Controls for SOX Compliance and IT Governance for Small and Medium Business
Javier Kuong
60 Min
Product Id: 700096
This Internal Controls and Governance training will guide you through Strategies and Controls for Small and Medium Business in SOX Compliance & IT Governance.
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Design for Six Sigma in Medical Devices: Integration with the FDA Quality Systems Regulations
Vinny Sastri
60 Min
Product Id: 700139
This Six sigma training in Medical device will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device. Design for Six Sigma (DFSS) can be used to design, manufacture and sell high quality, defect-free, safe, effective devices that meet the intended use while also generating healthy profit margins for the company.
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Auditing a Compliance and Ethics Program Evaluating the Design and Operating Effectiveness
Dan Swanson
60 Min
Product Id: 700238
This Auditing training will show you how to audit your compliance and ethics program and how to Evaluate the Design and Operating Effectiveness. Organizations are exposed to governance, compliance and ethical risks daily. Coupled with the current economic, regulatory and social climate, these risks have propelled corporate governance, compliance management and integrity to a top business priority
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Design Input: How to write requirements and modularize a product
Michelle Sullivan
60 Min
Product Id: 700517
In this Design Input training will define design input, review robust requirements development, assess the impact of User needs Vs Patient needs and discuss options for timing your design reviews. During this seminar, we will complete a sample Design Input requirements document that you can use as a guide for writing your own requirements
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FDA Compliance and Quality inspections
Sandra N. Whetstone
60 Min
Product Id: 700513
This FDA quality inspection training will focus on FDA’s current thinking on cGMP requirements, including background information on FDA’s inspectional requirements under the Food, Drug and Cosmetic Act. The Food and Drug Administration is using a new approach to inspections as a part of their cGMP Initiative for the 21st Century
Strategic Planning: Mapping and Measuring Strategy
Amie Devero
60 Min
Product Id: 700423
In this Strategic Planning training learn to map and measure the strategy and Creating metrics that will populate a balanced scorecard, allowing for the measurement of the strategy’s execution, and the measurement of its validity. Real strategy is one of the most poorly understood management areas. Most strategic planning consists of little more than issuing goals and assigning projects and tasks--then producing a giant tome that no one ever reads.
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Best Practices in Export Management Systems
Beth Peterson
60 Min
Product Id: 700479
In this Export management training learn how companies implement processes and systems that create a competitive advantage and drive compliance with the Export Administration Regulations.
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Selling Global: Essentials of Export Controls
David Ross
60 Min
Product Id: 700493
This Trade & Logistic training is designed for both management and tactical operations staff in understanding the rules of engagement for exporting your products globally.
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Using the FDA guidance General Principles of Software Validation to strengthen your firm's software FDA compliance
Dennis Moore
60 Min
Product Id: 700443
This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.
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Applying HACCP to insure compliance
Joyce Wilkins
60 Min
Product Id: 700466
This HACCP training will equip the student to apply the concepts of HACCP in their food operation in a manner that is useful and effective without being unduly burdensome. Although HACCP has been around for over 40 years, it still remains the standard in designing a food safety program.
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Designing in Quality via Statistical Process Control
Vinny Sastri
60 Min
Product Id: 700411
This statistical process control training will provide an overview of statistical process control (SPC) describe various types of control charts and how they can be used for trend analysis, defect reduction, product capability assessment. Quality, safety and efficacy must be designed into a product. Quality cannot be inspected or tested in the finished product.