• John Robinson

Latest listings

  • How to be Efficient and Compliant with Part 11, Validation

    How to be Efficient and Compliant with Part 11, Validation

    Data Management Massachusetts (Boston) November 29, 2018 Free

    Description: • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. • Many companies are outsourcing IT resources and getting in...

  • Promotion and Advertising Practices - FDA Scrutiny 2019

    Promotion and Advertising Practices - FDA Scrutiny 2019

    Training and Teaching California (SFO) November 29, 2018 Free

    Description: If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidanc...

  • HIPAA Privacy, Security, and Breach Notification Rules

    HIPAA Privacy, Security, and Breach Notification Rules

    Data Management California (SFO) November 29, 2018 Free

    Description: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associa...

  • Applied Statistics for FDA Process Validation 2019

    Applied Statistics for FDA Process Validation 2019

    Training and Teaching Philadelphia (Philadelphia) November 29, 2018 Free

    Description: In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production." The guidance furthe...

  • 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...

  • Compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

    Compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

    Other Services San Diego (California) October 25, 2018 1295.00 Dollar US$

    Description: • This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. • It det...

  • Compile a CE Marking Technical File 2018

    Compile a CE Marking Technical File 2018

    Training and Teaching (Zurich) October 25, 2018 1895.00 Dollar US$

    Description: Why you should attend • Introductions and overview of the EU Directives • Identify the EU Directives and standards applicable to your product • Comply with the implementation details and requirements of the EU MDR & IVDR • Design a n...

  • 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...