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Upcoming Events

Compliance4all

Equipment Validation, Tracking, Calibration and Preventive Maintenance

Fremont, CA
Overview:Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.

Aseptic Processing Overview and Validation 2019

Fremont, CA
Overview:This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

The FDA Inspection: Preparation, Management, and Follow - up

Fremont, CA
Overview:This webinar is designed to teach participants how to utilized MBSR techniques as a means to reduce stress and burnout, promote positive workplace functioning, and improve job satisfaction and productivity.

Implementing a Robust Data Integrity Program- 2019

Fremont, CA
Overview:Attendees will be presented with an overview of the audit trails within an application and the content of each one, Also Attendees will be presented with a list of records to identify if they are GMP records.

3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

Fremont, CA
Overview:In this webinar you will Learn how to navigate through FDA requirements, Ways to manage your presence in social media, How to identify an off-label problem and corrective action.

OneNote 2016 - Bringing Order to your Digital Chaos

Fremont, CA
Overview:Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality.

What is Human Factors and why is it Important?

Fremont, CA
Overview:This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals.

Theory and Practice of Near-Infrared Spectroscopy

Fremont, CA
Overview:NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts.

Device Changes, FDA Changes, and the 510(k)

Fremont, CA
Overview:Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based?

FDA Inspections - Do's and Don'ts 2019

Fremont, CA
Overview:In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.
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Past Events

European Data Protection Regulation - Latest 2019

European Data Protection Regulation - Latest 2019

Fremont, CA
Overview:Learn the common EU rules that have been established to ensure that personal data has a high standard of protection across the EU. Why should you Attend:Every day within the EU, businesses, public authorities and individuals transfer vast amounts of personal data across borders. Conflic...
Wednesday, February 20 2019 10:00 AM 11:30 AM

Human Machine Interface and Alarm Handling 2019

Human Machine Interface and Alarm Handling 2019

Fremont, CA
Overview:The Human Machine Interface within a control room is the main (and in some cases only) interface and operator has with the rest of a system. Therefore, the HMI, is an operator's primary source of data. Why should you Attend:This means that a single operator can oversee a greater range o...
Wednesday, February 13 2019 10:00 AM 11:00 AM

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Fremont, CA
Overview:This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Why should you Attend:This course will discuss the importance of establishing metrics, how to disting...
Tuesday, February 12 2019 10:00 AM 11:30 AM

Food Safety - Food Defense 2019

Food Safety - Food Defense 2019

Fremont, CA
Overview:Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to. Why should you Attend:This webinar will focus on Food Defense and will detail what an organization needs to have in place in or...
Friday, February 8 2019 10:00 AM 11:00 AM

GMP Environment- Best Practices for Foundational Employee Success

GMP Environment- Best Practices for Foundational Employee Success

Fremont, CA
Overview:FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a quality culture, and manage the work environment. W...
Wednesday, February 6 2019 10:00 AM 11:00 AM

Fishbone Diagramming 2019

Fishbone Diagramming 2019

Fremont, CA
Overview:Fishbone Diagramming is an analytical approach used to identify and solve problems. Analysis is presented in the Seven Basic Tools of Quality in addition to advanced methods used to increase organizations effectiveness, efficiency and reliability. Why should you Attend:Traditional metho...
Tuesday, February 5 2019 10:00 AM 11:00 AM

Medical Devices - Complying With Statistical Methods

Medical Devices - Complying With Statistical Methods

Fremont, CA
Overview:In this webinar you will learn how to structure your statistical procedures to ensure compliance, and how to avoid these and how to fully comply with the statistical regulations. Why should you Attend:Two of common 483 and Warning letter items are:Lack of valid statistical rationaleInad...
Monday, February 4 2019 10:00 AM 11:30 AM

Risk Based Incident Management and [CAPA for GxP] Operations

Risk Based Incident Management and [CAPA for GxP] Operations

Fremont, CA
Overview:This Webinar specifically addresses the Incident Management and CAPA  processes of the Operations phase of GxP Computerized Systems and  describes the development, implementation, and maintenance of  efficient, cost-effective, and compliant processes and procedures. Why should you At...
Thursday, January 31 2019 12:00 PM 3:00 PM

Power Pivot and Power Query 101 [BI tool]

Power Pivot and Power Query 101 [BI tool]

Fremont, CA
Overview:Power Pivot puts the "power" into Pivot Tables (hence the name!),  removing many of limitations and frustrations that many advanced  users find with Pivot Tables. Why should you Attend:If you work with, analyse and generate reports from large datasets,  having a good understanding an...
Wednesday, January 30 2019 10:00 AM 11:30 AM
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