• Compliance4All

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  • How Ensuring Data Integrity in Method Validations

    How Ensuring Data Integrity in Method Validations

    Data Management Fremont (California) December 8, 2017 Free

    Overview: The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity. Why should you Attend: The guidance changes how FDA regulated methods will be dev...

  • NDAs and INDs for Orally-Administered Drug Products

    NDAs and INDs for Orally-Administered Drug Products

    Training and Teaching Fremont (California) December 8, 2017 150.00 Dollar US$

    Overview: This webinar will be helpful to applicants conducting BA/BE studies during the IND period, also FDA guidance recommendations on how to meet the BA and BE requirements in 21 CFR 320 as they apply to oral dosage forms. Why should you Attend: ...

  • Learn Some of the Acceptance Activities in FDA QSR

    Learn Some of the Acceptance Activities in FDA QSR

    Clinical/Medical Sciences Fremont (California) December 8, 2017 Check with publisher

    Overview: This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively. Why should you Attend: As you ensure that your Quality Man...

  • Underutilized and Underappreciated in Management Control

    Underutilized and Underappreciated in Management Control

    Medical - Health Fremont (California) December 8, 2017 Check with publisher

    Overview: In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Why should you Attend: Management with executive responsibility i...

  • How to Comply with both in the Same Organization

    How to Comply with both in the Same Organization

    Medical - Health Fremont (California) December 8, 2017 Check with publisher

    Overview: This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for ...

  • Final Rules of Unique Device Identification

    Final Rules of Unique Device Identification

    Training and Teaching Fremont (California) December 8, 2017 150.00 Dollar US$

    Overview: This webinar will address the four key steps to compliance by device manufacturers. Also covered will be the Final Rule's provisions to address existing FG inventory, not properly labeled. Why should you Attend: It will also review the impl...

  • How to plan risk based approaches for clinical trials

    How to plan risk based approaches for clinical trials

    Clinical Fremont (California) December 8, 2017 Free

    Overview: You will understand how to identify, evaluate and also how to implement specific risk based techniques for risk management used in clinical trials. Areas Covered in the Session: Have explained key risk based process/tools and techniques Rev...

  • Practices for Active Pharmaceutical Ingredients per ICH Q7

    Practices for Active Pharmaceutical Ingredients per ICH Q7

    Clinical Fremont (California) December 8, 2017 Free

    Overview: The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes. Why should you Attend: This document was created to fulfil the need for specific guidance with re...

  • Why Capturing Justifications in Change Control

    Why Capturing Justifications in Change Control

    Clinical/Medical Sciences Fremont (California) December 8, 2017 Check with publisher

    Overview: It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released ...

  • How to Accurate Adverse Event Reporting

    How to Accurate Adverse Event Reporting

    Training and Teaching Fremont (California) December 8, 2017 150.00 Dollar US$

    Overview: Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices uti...