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  • 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...

  • Tougher Import Rules for FDA Imports in 2018

    Tougher Import Rules for FDA Imports in 2018

    Data Management Raleigh (North Carolina) October 25, 2018 1495.00 Dollar US$

    Description: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly e...

  • Excel Spreadsheet Validation 2018 Tools and Techniques

    Excel Spreadsheet Validation 2018 Tools and Techniques

    Clinical Salt Lake City (Utah) October 25, 2018 1495.00 Dollar US$

    Description: Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multiva...

  • Introduction to Adaptive Design for Clinical Trials

    Introduction to Adaptive Design for Clinical Trials

    Quality Control, Safety & Security Philadelphia (Pennsylvania) October 25, 2018 1495.00 Dollar US$

    Description: This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs. The role of statistics in clinical trials incorporates the too...

  • HIPAA Compliance - Clear, Complete, Step-by-Step

    HIPAA Compliance - Clear, Complete, Step-by-Step

    Training and Teaching San Diego (California) October 25, 2018 1495.00 Dollar US$

    Description: Organizations of all types and sizes continue to struggle needlessly with HIPAA Compliance. For example, HIPAA Risk Analysis – Risk Management is the basis of the HIPAA Compliance Program of every Covered Entity and Business Associate. B...

  • Quality by Design - Essential Techniques for Medical Devices

    Quality by Design - Essential Techniques for Medical Devices

    Chemical Methods San Diego (California) October 25, 2018 1495.00 Dollar US$

    Description: Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter ob...

  • OSHA Recordkeeping and Surviving an OSHA Audit

    OSHA Recordkeeping and Surviving an OSHA Audit

    Clinical New Orleans (Louisiana) October 25, 2018 1495.00 Dollar US$

    Description: The Occupational Safety and Health Administration (OSHA) has jurisdiction to protect the workers of America and its territories from harmful working conditions. They are a department under the US Department of Labor and was given the leg...

  • Applied Statistics for Scientists and Engineers seminar at Boston

    Applied Statistics for Scientists and Engineers seminar at Boston

    Training and Teaching Boston (Massachusetts) October 25, 2018 1495.00 Dollar US$

    Description: Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measu...

  • Japan Regulatory Compliance Requirements for Life Science Products

    Japan Regulatory Compliance Requirements for Life Science Products

    Drug Development Seattle (Washington) September 5, 2018 1495.00 Dollar US$

    Course "Japan Regulatory Compliance Requirements for Life Science Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-Day seminar covers the detai...

  • Drug Master Files and Quality Agreement Training Seminar 2018

    Drug Master Files and Quality Agreement Training Seminar 2018

    Drug Development Philadelphia (PA,PA) March 6, 2018 1495.00 Dollar US$

    Overview: This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings be...

  • Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

    Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

    Training and Teaching SFO, CA (SFO, CA) October 23, 2017 1495.00 Dollar US$

    Course "Data Integrity, 21 CFR 11 & Annex 11 Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The Problem: We have all heard of Data Integri...

  • Regulatory Requirements and Principles for Cleaning Validation 2017

    Regulatory Requirements and Principles for Cleaning Validation 2017

    Training and Teaching San Diego, CA ( San Diego, CA) October 23, 2017 1495.00 Dollar US$

    Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2day course will cover practical g...