Quality Control, Safety & Security

Listings
  • What to Expect in a Federal HIPAA Audit & How to Avoid Audit 2017

    What to Expect in a Federal HIPAA Audit & How to Avoid Audit 2017

    Quality Control, Safety & Security Richmond, VA (Courtyard by Marriott Richmond Downtown) August 23, 2017 1295.00 Dollar US$

    Overview: I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). It seems al...

  • Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices 2017

    Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices 2017

    Quality Control, Safety & Security Las Vegas, NV (DoubleTree by Hilton Las Vegas Airport) August 23, 2017 1295.00 Dollar US$

    Course "Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Design Contro...

  • Biostatistics for the Non-Statistician 2017

    Biostatistics for the Non-Statistician 2017

    Quality Control, Safety & Security Washington, DC (Courtyard Arlington Crystal City) August 23, 2017 1295.00 Dollar US$

    Course "Biostatistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Statistics is a useful decision making tool in the clinical res...

  • Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory

    Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory

    Quality Control, Safety & Security Washington, DC (Courtyard Arlington Crystal City) August 23, 2017 1295.00 Dollar US$

    Course "Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC...

  • HIPAA - Understanding Compliance Program Requirements 2017

    HIPAA - Understanding Compliance Program Requirements 2017

    Quality Control, Safety & Security Atlantic City, NJ (Courtyard by Marriott Atlantic City) August 23, 2017 1295.00 Dollar US$

    Overview: Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that you also have the proper policies and procedures i...

  • Drug dissolution testing and establishing plasma drug levels in humans 2017

    Drug dissolution testing and establishing plasma drug levels in humans 2017

    Quality Control, Safety & Security San Diego, CA (DoubleTree by Hilton San Diego Downtown) August 23, 2017 1295.00 Dollar US$

    Course "Drug dissolution testing and establishing plasma drug levels in humans" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Drug dissolution testing is an ...

  • Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

    Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

    Quality Control, Safety & Security San Diego, CA (Four Points By Sheraton San Diego Downtown) August 23, 2017 1295.00 Dollar US$

    Course "Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Medical Device manufacturers...

  • Tougher Import Rules for FDA Imports in 2017

    Tougher Import Rules for FDA Imports in 2017

    Quality Control, Safety & Security Los Angeles, CA (Four Points by Sheraton Los) August 23, 2017 1295.00 Dollar US$

    Course "Tougher Import Rules for FDA Imports in 2017" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: Background: FDA and the Customs and Border Patrol Service ...

  • The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2017

    The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2017

    Quality Control, Safety & Security Las Vegas, NV (Las Vegas, NV) January 10, 2017 1295.00 Dollar US$

    Overview: We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU's M...

  • Applying U.S. FDA Laws and Regulations 2017

    Applying U.S. FDA Laws and Regulations 2017

    Quality Control, Safety & Security SFO, CA (United States ) January 10, 2017 1295.00 Dollar US$

    Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop ...

  • Effective Complaint Handling, Medical Device Reporting and Recalls 2017

    Effective Complaint Handling, Medical Device Reporting and Recalls 2017

    Quality Control, Safety & Security San Diego, California (United States ) January 10, 2017 1295.00 Dollar US$

    Overview: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed...

  • Extracting information from geochemical data 2017

    Extracting information from geochemical data 2017

    Quality Control, Safety & Security Houston, TX (United States ) January 10, 2017 1295.00 Dollar US$

    Course "Extracting information from geochemical data" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Most specialists strongly recommend to sample every meter...