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  • The New FDA-Product Approval Web Conference by Compliance4all

    The New FDA-Product Approval Web Conference by Compliance4all

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

    Overview: The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration. The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting ma...

  • Compliance with FDA and ISO Requirements Web Conference by Compliance4all

    Compliance with FDA and ISO Requirements Web Conference by Compliance4all

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

    Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regar...

  • The Investigational Medicinal Product Dossier Web Conference by Compliance4all

    The Investigational Medicinal Product Dossier Web Conference by Compliance4all

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

    Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an F...

  • Sampling Plans for Risk Management in Incoming QC Web Conference by Compliance4all

    Sampling Plans for Risk Management in Incoming QC Web Conference by Compliance4all

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

    Overview: The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are pr...

  • FDA Regulation of Combination Products Web Conference by Compliance4all

    FDA Regulation of Combination Products Web Conference by Compliance4all

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

    Overview: A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Why Should you Attend: To gain a fundame...

  • 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...

  • 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...