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  • Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

    Regulatory Filing Requirements and Compliance Processes for Medical Devices 2017

    Quality Control, Safety & Security Zurich, Switzerland (Hilton Zurich Airport) August 23, 2017 1695.00 Dollar US$

    Course "Japan - Regulatory Filing Requirements and Compliance Processes for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: • Japan's classifi...

  • 21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

    21 CFR Part 11 compliance for software validation and SaaS/Cloud 2017

    Quality Control, Safety & Security Zurich, Switzerland (Hilton Zurich Airport) August 23, 2017 1695.00 Dollar US$

    Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: • This interactive two-day course exp...

  • 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...

  • Incorporating Risk Management into Your HR Policy 2017

    Incorporating Risk Management into Your HR Policy 2017

    Quality Control, Safety & Security Los Angeles, CA (Four Points by Sheraton ) August 23, 2017 1095.00 Dollar US$

    Overview: HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key c...

  • HR Auditing Identifying and Managing Key Risks 2017

    HR Auditing Identifying and Managing Key Risks 2017

    Quality Control, Safety & Security SFO, CA (Hilton San Francisco Airport Bayfront) August 23, 2017 895.00 Dollar US$

    Overview: HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key c...

  • Validation, Verification and Transfer of Analytical Methods 2017

    Validation, Verification and Transfer of Analytical Methods 2017

    Training and Teaching SFO, CA (Hilton San Francisco Airport Bayfront) August 23, 2017 1295.00 Dollar US$

    Course "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon...

  • 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...

  • FDA's Latest Regulations for Computer Systems Used in the Tobacco 2017

    FDA's Latest Regulations for Computer Systems Used in the Tobacco 2017

    Training and Teaching Richmond, VA (Courtyard by Marriott Richmond Downtown) August 23, 2017 1295.00 Dollar US$

    Course "FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. O...

  • 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...

  • Guidance on Software and Device Changes and the 510(k)

    Guidance on Software and Device Changes and the 510(k)

    Drug Development Fremont (California) August 14, 2017 Free

    Overview: The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Why should you Attend: Anyone who is involved in software a...

  • NIST Cybersecurity Framework For Computer Systems Validation

    NIST Cybersecurity Framework For Computer Systems Validation

    Quality Control, Safety & Security Fremont (California) August 14, 2017 Free

    Overview: Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal informatio...

  • Batch Record Review and Product Release - 2017

    Batch Record Review and Product Release - 2017

    Drug Development Fremont (California) August 14, 2017 Free

    Overview: A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. Why should you Attend: ...