
Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer
Vinny Sastri
60 Min
Product Id: 700536
This Design Controls Webinar will provide a overview of all the steps involved in design controls and explain and clarify and state specific requirements in the regulations.

Viral Validation for Biopharmaceuticals
Kathryn Martin Remington
60 Min
Product Id: 700187
This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.

Quality & Finance: Creating a Balance Using Lean Principles
Tom Zidel
60 Min
Product Id: 700551
This healthcare webinar will give an introduction to lean in healthcare which includes an illustrative exercise to aid participants in understanding the basic underlying concept of lean.

The In's and Out's of FLSA: Fair Labor Standards Act
Jarik E Conrad
60 Min
Product Id: 700545
This workshop will provide an overview of FLSA and its four provisions: (1) Minimum wage; (2) Hours of work; (3) Child labor; and (4) Equal pay

How to audit-Proof your tax return while saving money on your taxes
Patrick P Astre
60 Min
Product Id: 700559
This is the Webinar your accountant probably will not tell you about and the IRS hopes you never find

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.

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.

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.

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.

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? .

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.

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.

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.

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.

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.

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.

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

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

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.