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.
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.
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.
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.
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.
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.
Common Problems and Mistakes in Method Validation in drug development process
Dr. Wise Blackman
60 Min
Product Id: 700267
This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. This web seminar will address frequently observed issues and problems with method validations.
Now I get it: The Progressive Discipline Process
Dethra Giles
60 Min
Product Id: 700499
This HR compliance training will present this common term as a way for manager to present employees with options with the ultimate goal of improving the work environment and not the goal of "getting rid" of an employee.
C-TPAT - Standard Operating Procedures for Security in the Supply Chain
Karma Ruiz,Charlie Hocker
60 Min
Product Id: 700488
In this C-TPAT training we will walk you through the most effective processes we have developed and how they can be customized for your company.
Making FMEA a More Efficient and Powerful Patient Safety Improvement Tool
Patrice Spath
60 Min
Product Id: 700396
This FMEA (Failure mode and effects analysis) training will cover the Joint Commission requirements for conducting a proactive risk assessment using the FMEA methodology.
Getting Clear: Establishing Performance Expectations for Employees
Marnie Green
60 Min
Product Id: 700468
In this HR compliance training we explore why there is often a difference between what the manager expects and the employee delivers. One of the most frustrating parts of being a manager is having expectations of an employee and finding the employee’s performance falls short of meeting those expectations.
Pharmaceutical Manufacturing Process Validation
Rodney E Thompson
60 Min
Product Id: 700480
This process validation training for Pharmaceutical Manufacturers will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection. Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license.
Effective Employee Performance Documentation: Elements and Techniques
Marnie Green
60 Min
Product Id: 700467
This Performance Documentation training will explore the elements of effective documentation and will offer practical useful tips for creating an environment where maintaining performance documentation is an easy part of the manager’s routine. Any employee status change that is based on performance (reassignment, demotion, termination) must be supported by adequate documentation.
C-TPAT - annual training for employees to fulfill C-TPAT requirements by CBP
Karma Ruiz,Charlie Hocker
60 Min
Product Id: 700487
This C-TPAT training will guide you on the annual training for employees to fulfill C-TPAT requirements by CBP.
How to set up a small-volume radiopharmaceuticals manufacturing facility
Shankar Seetharaman
60 Min
Product Id: 700475
This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence