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ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products
John E Lincoln
60 Min
Product Id: 700708
An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.
1825 Sexual Harassment Prevention Training
Scott Baird
60 Min
Product Id: 700596
This program teaches the employees of your organization what harassment is and what their responsibility is in reporting and preventing it. It is a sensitive topic, even though major portions of the work force, both men and women, have been affected.
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Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation
Dennis Moore
60 Min
Product Id: 700192
Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.
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Cleanroom Operation, Maintenance and Operators
Nazia Dar
Product Id: 700630
Attendees will learn and understand the do’s & don’t of the cleanroom procedures during cleaning, disinfecting, transferring of material and filling operations. This one-hour online seminar is designed to discuss the principles applied to the operation and cleaning of cleanrooms to ensure the contamination control.
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Email Usage/E-Compliance - Don't Get Caught on the Bottom of the Spamming Pile
Sheila Rae
60 Min
Product Id: 700548
With the fast growing world market and the desire to communicate in a fast and effective manner, many of us rely on instant communication to make client connections.
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A Beginners Guide to Importing Medical Devices
Jennifer Diaz
60 Min
Product Id: 700701
This seminar is intended to assist with a basic overview of what medical devices are... Seminar is to inform the international trade and transportation community regarding the FDA policies and procedures related to medical devices.
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Infection Control Commissioning for Health Care Construction Projects
Laurence Lee(CIH)
60 Min
Product Id: 700700
This webinar will provide valuable assistance to all healthcare organizations and institutions; architecture and construction management companies; infection control practitioners and industrial hygienists; joint commission verifiers and reviewers, and construction companies engaged in healthcare construction projects.
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How to Put Together An Effective Audit Program
Deborah Donaldson
60 Min
Product Id: 700285
This program will lay the foundation for subsequent webinars. but can be used as a starting point for the development of any audit program. The goal is to have a program that is comprehensive enough to guide the auditor(s) through the testing of an adequate number of areas, the documentation of the findings and conclusions based on quantitative data, and the presentation and recommendations based on the findings
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Effective Method Transfer of Complex Bioassays
Ana Menendez
60 Min
Product Id: 700636
This Bioassays training/webinar will systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.
Introduction to Defense Trade Controls, ITAR - best-practice strategies to make your program compliant and effective
Natascha Finnerty
60 Min
Product Id: 700696
This presentation will present the major items that your company’s Technology Control Plan and Compliance program must contain. Emphasized are best-practice strategies to make your program compliant and effective.
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Sexual Harassment Awareness & Prevention Training for Managers
David J Zetter
60 Min
Product Id: 700440
This presentation will develop awareness for harassment issues in the workplace and educate you on how to prevent issues.
The latest approach for complying with 21 CFR Part 11
Sam Mistretta
60 Min
Product Id: 700664
This 21 CFR Part 11 training/webinar will provide valuable assistance to all regulated companies that need to comply with 21 CFR Part 11.
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Free Zone and Bonded Warehouse Compliance
Cynthia Cabrera
60 Min
Product Id: 700572
In this Free Zone and Bonded Warehouse Compliance training/webinar learn the pitfalls and possible repercussions non-compliance in these government directed entities.
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Developing an Employee Handbook
David J Zetter
60 Min
Product Id: 700441
This HR Compliance training/webinar in developing hand book will helps in developing an effective employee handbook and what are the policies should you include in your hand book.
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Management Controls Under QSR and ISO 13485
Jeff Kasoff
60 Min
Product Id: 700320
This Management Controls Under QSR and ISO 13485 training/webinar will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality plan, and of course all aspects of management reviews.
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Quality Planning Process and Procedure
Ronald Schoengold
60 Min
Product Id: 700665
This Quality Planning training/webinar will define the Quality policy and plan with the help of procedure, Manual and templates where manufacturer decides how to apply these regulatory guidelines in developing a plan that consistently delivers high quality products and services.
Overview of the Harmonized Tariff Schedule of the United States - Classifying Your Products for Customs Purposes
Paula Connelly
60 Min
Product Id: 700659
This Harmonized Tariff Schedule of the United States training/webinar will provide an overview of the structure of the HTSUS and how to use the HTSUS to determine the correct classification, duty rate, and possible quotas, restrictions or preferential duty rates that may be applicable to your product.
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Sarbanes-Oxley, IT and Segregation of Duties
George Spafford
60 Min
Product Id: 700112
This segregation of duties (SOD) training/webinar in Sarbanes-Oxley and IT will provide an overview of the current interpretation of Sarbanes-Oxley and will talk about what risks that Sarbanes-Oxley is especially concerned with when it comes to segregation of duties.
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Interviewing and Hiring in Compliance with Federal and State Laws
Marna Hayden
60 Min
Product Id: 700647
The HR Compliance training/webinar in Interviewing and Hiring will cover various interviewing techniques and the processes used to make effective selection decisions.
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Validation of Potency Bioassays for Biologicals
Ana Menendez
60 Min
Product Id: 700201
This Validation of Potency Bioassays training/webinar for Biologicals provides logical approaches that should be implemented during early development to increase predictability and deliver rugged, compliant assays through Phase III and commercialization.