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Upcoming Events

Compliance4all

Letters of Credit are issued under the Customs and Practice 2017

Fremont, CA
Overview:Letters of Credit are the primary instruments for assuring payment of goods sold internationally. Letters of Credit are issued under the Uniform Customs and Practice standard and can be negotiated by over 30,000 b... read more

Medical Devices for Risk Management Techniques 2017

Fremont, CA
Overview:This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

Excel Methods - FDA Device Regulations - 2017

Fremont, CA
Overview:FDA regulations cover both the use of workbooks and the creation of electronic records device manufacturers must understand these regulations and their application. The presentation begins with Excel methods to he... read more

Clinical Trials - Medical Device FDA's Program 2017

Fremont, CA
Overview:The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product.

Stress-Testing for Financial Institutions - 2017

Fremont, CA
Overview:Stress-testing requires lateral knowledge and skills to be thoroughly pursued
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Past Events

ISO 14971 Hazard Analysis at Medical Device - 2017

ISO 14971 Hazard Analysis at Medical Device - 2017

Fremont, CA
Overview:  The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Why should you Attend: FDA expects that as part of a product development program r...
Thursday, August 17 2017 10:00 AM 11:00 AM

Environmental Monitoring Program at FDA Regulations - 2017

Environmental Monitoring Program at FDA Regulations - 2017

Fremont, CA
Overview:  Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring. Why should you Attend:The cost of non-compliance is therefore more ...
Thursday, August 10 2017 10:00 AM 11:00 AM

Laboratory-Developed Tests - Medical devices 2017

Laboratory-Developed Tests - Medical devices 2017

Fremont, CA
Overview:This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. Why should you Attend:...
Thursday, August 10 2017 10:00 AM 11:00 AM

CAPA within a Device Quality System - 2017

CAPA within a Device Quality System - 2017

Fremont, CA
Overview:You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you. Why should you Attend:Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And y...
Wednesday, August 9 2017 10:00 AM 11:00 AM

FDA Inspection and Respond to 483 & How to Prepare them - 2017

FDA Inspection and Respond to 483 & How to Prepare them - 2017

Fremont, CA
Overview:In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A...
Tuesday, August 8 2017 10:00 AM 11:00 AM

Achieving Compliance Excellence - 2017

Achieving Compliance Excellence - 2017

Fremont, CA
Overview:We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization.  Why should you Attend:Because as much as we try, most regulated industries don't have a set approach for developing a compliance p...
Friday, August 4 2017 10:00 AM 11:00 AM

Validation Program to a Building from Top to Bottom - 2017

Validation Program to a Building from Top to Bottom - 2017

Fremont, CA
Overview:Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program.  Why you should attend:How PLC-based systems or laboratory equipment should fall wit...
Friday, August 4 2017 10:00 AM 11:00 AM

Effective Supplier Qualification Program - 2017

Effective Supplier Qualification Program - 2017

Fremont, CA
Overview:FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.  Areas Covered in the Session:Learn the pre-selection, selection...
Thursday, August 3 2017 10:00 AM 11:30 AM

Cyber Attacks, Beyond Disaster Recovery - 2017

Cyber Attacks, Beyond Disaster Recovery - 2017

Fremont, CA
Overview:Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matter of if an attack will occur, only when. Why should you Attend:A poor res...
Tuesday, August 1 2017 10:00 AM 11:30 AM

Control Change in Medical Device Engineering - 2017

Control Change in Medical Device Engineering - 2017

Fremont, CA
Overview:  This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. Why should you Attend:FDA and ISO call for change control but do not pr...
Thursday, July 27 2017 10:00 AM 11:00 AM
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