Drug Development

Listings
  • 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...

  • 6-Hour Virtual Seminar on Batch Record Review and Product Release

    6-Hour Virtual Seminar on Batch Record Review and Product Release

    Drug Development Fremont (California) July 3, 2019 545.00 Dollar US$

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate c...

  • Verification vs Validation-Product, Equipment and QMS Software

    Verification vs Validation-Product, Equipment and QMS Software

    Drug Development Fremont (California) June 15, 2018 290.00 Dollar US$

    Overview: You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements, ISO 14971 and IEC 62366 considerations, as approp...

  • Introduction to Sales and Use Taxation

    Introduction to Sales and Use Taxation

    Drug Development Fremont (California) May 23, 2019 150.00 Dollar US$

    Overview: In this webinar you will Learn how to determine whether the tax basis is equal to the sale of property or sale of services or both (the states are inconsistent), Also Learn the difference between a sales tax and a use tax. Why should you At...

  • Expectations for Products Used in Early Phase

    Expectations for Products Used in Early Phase

    Drug Development Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guida...

  • Compliance for Electronic Records and Signatures 2018

    Compliance for Electronic Records and Signatures 2018

    Drug Development Fremont (California) February 22, 2018 150.00 Dollar US$

    Overview: This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session: Which data and systems are subject to Part 11 What Part 11 means to...

  • Medical Device Single Audit Program Preparation

    Medical Device Single Audit Program Preparation

    Drug Development Fremont (California) February 22, 2018 150.00 Dollar US$

    Overview: The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. Why should you A...

  • Fraud & Abuse, Stark & Anti-Kickback Issues

    Fraud & Abuse, Stark & Anti-Kickback Issues

    Drug Development Fremont (California) December 4, 2019 139.00 Dollar US$

    Overview: The presentation will provide an overview of the Federal Stark and Anti-Kickback laws and corresponding regulations including the history and purpose of these laws. The presenter will provide the background upon which these laws were determ...

  • HIPAA Violations - Social Media, Web Sites, Patient Reviews

    HIPAA Violations - Social Media, Web Sites, Patient Reviews

    Drug Development Fremont (California) March 1, 2019 139.00 Dollar US$

    Overview: Patient Engagement is a cornerstone of quality patient care and Web Sites and Social Media are indispensable patient engagement tools. Provider Web Sites and Social Media are inexpensive, easy to build and almost universal today. HIPAA law ...

  • Dealing with the Disruptive Practitioner in a Legally Compliant Manner

    Dealing with the Disruptive Practitioner in a Legally Compliant Manner

    Drug Development Fremont (California) March 1, 2019 139.00 Dollar US$

    Overview: Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations. Why...

  • Clinical Documentation Improvement: Moving to Improve Patient Outcomes

    Clinical Documentation Improvement: Moving to Improve Patient Outcomes

    Drug Development Fremont (California) March 1, 2019 139.00 Dollar US$

    Overview: Achieving high performing quality focused patient centered cost-effective outcomes based clinical care requires a multidisciplinary approach to delivering patient care. Why should you Attend: Accurate reporting and reflection of patient out...