• John Robinson

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  • Effective Complaint Handling, Medical Device Reporting and Recalls

    Effective Complaint Handling, Medical Device Reporting and Recalls

    Pharmacology - Drug Development Baltimore (Maryland) December 6, 2019 Check with publisher

    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, and corr...

  • Applied Statistics for Scientists and Engineers

    Applied Statistics for Scientists and Engineers

    Clinical/Medical Sciences SFO (California) December 6, 2019 Check with publisher

    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 measurement system...

  • 2-day In-person Seminar FDA and U.S. Customs Import Rules and Export Traps in 2020

    2-day In-person Seminar FDA and U.S. Customs Import Rules and Export Traps in 2020

    Quality Control, Safety & Security Washington (Washington, DC) August 8, 2019 2000.00 Dollar US$

    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 execute an imp...

  • 2-day In-person Seminar Applied Statistics for FDA Process Validation

    2-day In-person Seminar Applied Statistics for FDA Process Validation

    Other Services Philadelphia (Philadelphia, PA) August 8, 2019 2000.00 Dollar US$

    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 further delineates...

  • 2-day In-person Seminar Death by CAPA - Does your CAPA Program need a CAPA?

    2-day In-person Seminar Death by CAPA - Does your CAPA Program need a CAPA?

    Training and Teaching Philadelphia (Philadelphia, PA) August 8, 2019 2000.00 Dollar US$

    This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compl...

  • Validation and 21 CFR Part 11 Compliance of Computer Systems

    Validation and 21 CFR Part 11 Compliance of Computer Systems

    Data Management Fremont (California) July 3, 2019 545.00 Dollar US$

    This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity....

  • Texting and E-mail with Patients - Meeting Patient Requests within the HIPAA Rules

    Texting and E-mail with Patients - Meeting Patient Requests within the HIPAA Rules

    Training and Teaching Fremont (California) July 3, 2019 545.00 Dollar US$

    E-mail has long been a staple of people's lives, but as we move into the new digital age, it seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used for health care purposes, including the use of e-...

  • 6-Hour Virtual Seminar on Clinical Data Management - Part II

    6-Hour Virtual Seminar on Clinical Data Management - Part II

    Quality Control, Safety & Security Fremont (California) July 3, 2019 545.00 Dollar US$

    When new drugs or devices are tested in humans, the data generated by, and related to, these trials are known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is...

  • The EU Clinical Trial Regulation - EU Filings & Registrations

    The EU Clinical Trial Regulation - EU Filings & Registrations

    Quality Control, Safety & Security Fremont (California) July 3, 2019 545.00 Dollar US$

    This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory...

  • 6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2019

    6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2019

    Data Management Fremont (California) July 3, 2019 545.00 Dollar US$

    Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection ...