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  • Chemistry 101 for Medical Device Regulatory Web Conference by Compliance4all

    Chemistry 101 for Medical Device Regulatory Web Conference by Compliance4all

    Other Services Online (California) November 11, 2016 150.00 Dollar US$

    Overview: Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect...

  • Device Changes, FDA Changes, and the 510(k) Web Conference by Compliance4all

    Device Changes, FDA Changes, and the 510(k) Web Conference by Compliance4all

    Other Services Online (California) November 11, 2016 150.00 Dollar US$

    Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when ...

  • Effective Training Practices for FDA Compliance Web Conference by Compliance4all

    Effective Training Practices for FDA Compliance Web Conference by Compliance4all

    Other Services Online (California) November 11, 2016 150.00 Dollar US$

    Overview: No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspecto...

  • The Marriage of the PFMEA and Control Plan Web Conference by Compliance4all

    The Marriage of the PFMEA and Control Plan Web Conference by Compliance4all

    Other Services Online (California) November 11, 2016 150.00 Dollar US$

    Overview: Come celebrate the union of the PFMEA and the CP! See how the Dynamic Control Plan (DCP) combines both tools into ONE enabling the savings of hundreds of hours of Engineering time, reducing the risk of documentation errors, and, actually im...

  • ISO 13485 & ISO 9001 - How to Choose Which One to Implement

    ISO 13485 & ISO 9001 - How to Choose Which One to Implement

    Other Services Fremont (California) February 22, 2018 150.00 Dollar US$

    Overview: This webinar will review the benefits of implementing a QMS, discuss the applicability of each standard to different types of organizations, and go on to explain the similarities, key differences, scope, and application of these standards t...

  • Understanding and Meeting your Regulatory & Processing Responsibilities

    Understanding and Meeting your Regulatory & Processing Responsibilities

    Other Services Fremont (California) February 22, 2018 150.00 Dollar US$

    Overview: Why DMFs are important to you and your company , and How DMFs fit into FDA's regulatory processes for review of drug and biologic applications. Areas Covered in the Session: Why DMFs are important to you and your company How DMFs fit into F...

  • OOS Test Results and Completing [Robust] Investigations

    OOS Test Results and Completing [Robust] Investigations

    Other Services Fremont (California) September 12, 2018 150.00 Dollar US$

    Overview: This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA). Why should you Att...

  • Drug Substances and Drug Products - Specifications

    Drug Substances and Drug Products - Specifications

    Other Services Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: This program will teach you to set specificatons for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies. Why should you Attend: Learn the recommendati...

  • Networking for Fun and Profit

    Networking for Fun and Profit

    Other Services Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: Most people lack the basic networking skills necessary to do their jobs properly. These networking skills help us in many areas of our jobs. Why should you Attend: Worried that you could be passed up for that promotion because someone else ...

  • Write an Effective Standard Operating Procedure

    Write an Effective Standard Operating Procedure

    Other Services Fremont (California) January 24, 2018 150.00 Dollar US$

    Overview: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Why should you Attend: Standard Oper...

  • European Data Protection Regulation - 2018 Implementation

    European Data Protection Regulation - 2018 Implementation

    Other Services Fremont (California) January 24, 2018 150.00 Dollar US$

    Overview: An overview of the history of Data Protection within the EU and introduce you to the enhancements and new obligations imposed by the EU GDPR. Why should you Attend: Attendees will learn the common EU rules that have been established to ensu...

  • Aware of the Similarities and Differences in the files

    Aware of the Similarities and Differences in the files

    Other Services Fremont (California) November 27, 2017 150.00 Dollar US$

    Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Why should you Attend: companies go global, they must mee...