Quality Control, Safety & Security

Listings
  • What you Need to Know to Prepare FDA Inspection

    What you Need to Know to Prepare FDA Inspection

    Quality Control, Safety & Security Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently ...

  • What are the Tools required for Human Error Reduction

    What are the Tools required for Human Error Reduction

    Quality Control, Safety & Security Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues. Areas Covered in the Session: Bac...

  • Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Quality Control, Safety & Security Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, an...

  • cGMPs in the Quality Control Laboratory (Medical 2018)

    cGMPs in the Quality Control Laboratory (Medical 2018)

    Quality Control, Safety & Security Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and ...

  • Good Documentation Guideline (Chapter 1029 USP)

    Good Documentation Guideline (Chapter 1029 USP)

    Quality Control, Safety & Security Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system. Why should you Attend: GDP is part of GMP and if you know it by heart, it preve...

  • FDA New Draft Guidance on (Software) and Device Changes 510k

    FDA New Draft Guidance on (Software) and Device Changes 510k

    Quality Control, Safety & Security Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a) (3)) that is not subject to PM...

  • Fundamentals of Risk Management in Clinical Research 2018

    Fundamentals of Risk Management in Clinical Research 2018

    Quality Control, Safety & Security Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at th...

  • FDA Inspection and Respond to 483 & How to Prepare them - 2017

    FDA Inspection and Respond to 483 & How to Prepare them - 2017

    Quality Control, Safety & Security Fremont (California) June 14, 2017 150.00 Dollar US$

    Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is requi...

  • HR Auditing Identifying and Managing Key Risks 2017

    HR Auditing Identifying and Managing Key Risks 2017

    Quality Control, Safety & Security SFO, CA (Hilton San Francisco Airport Bayfront) August 23, 2017 895.00 Dollar US$

    Overview: HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key c...

  • HR Auditing: Identifying and Managing Key Risks 2017

    HR Auditing: Identifying and Managing Key Risks 2017

    Quality Control, Safety & Security Washington, DC ( Washington, DC) October 23, 2017 895.00 Dollar US$

    Overview: HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key c...

  • Incorporating Risk Management into Your HR Policy 2017

    Incorporating Risk Management into Your HR Policy 2017

    Quality Control, Safety & Security Los Angeles, CA (Four Points by Sheraton ) August 23, 2017 1095.00 Dollar US$

    Overview: HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key c...

  • FDA's Software Monsters Cybersecurity, Interoperability, Mobile Apps 2017

    FDA's Software Monsters Cybersecurity, Interoperability, Mobile Apps 2017

    Quality Control, Safety & Security SFO, CA (SFO, CA) July 14, 2017 1295.00 Dollar US$

    Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Software's level of...