Training and Teaching

Listings
  • Computer System Validation 2018 Fundamentals

    Computer System Validation 2018 Fundamentals

    Training and Teaching Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than test...

  • Information Technology - Control Procedures in Regulated Industries

    Information Technology - Control Procedures in Regulated Industries

    Training and Teaching Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will be discussed. Why should you Attend: GxP/GMP regulations are required to be used in regulated indus...

  • What you need to know to Meet FDA and International Quality Standards

    What you need to know to Meet FDA and International Quality Standards

    Training and Teaching Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality. Why should you Attend: Compressed air is often overlooked as a ...

  • Complying with the Revenue Recognition Standard

    Complying with the Revenue Recognition Standard

    Training and Teaching Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: This FASB revenue recognition standard webinar will discuss the various steps involved in this standard and also the technical guidance to prepare a revenue recognition model. Why should you Attend: This course is designed to provide an ove...

  • Project Management for Non-Project Managers - Building the Project Team

    Project Management for Non-Project Managers - Building the Project Team

    Training and Teaching Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: The subject of this webinar is building the project team, The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team member's ongoing commitment to the successful comple...

  • Project Management for Non-Project Managers (2018 Estimating Resource Needs)

    Project Management for Non-Project Managers (2018 Estimating Resource Needs)

    Training and Teaching Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: This webinar will explore how to most effectively apply both the human and non-human resources to project tasks that you require to achieve your project's outcome.Once you have identified and allocated your available resources, you must "le...

  • Compliance for Risk Based Approaches for (Clinical Trials 2018)

    Compliance for Risk Based Approaches for (Clinical Trials 2018)

    Training and Teaching Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to ...

  • Best Practices for Foundational (Employee) Success 2018

    Best Practices for Foundational (Employee) Success 2018

    Training and Teaching Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a qual...

  • Cloud Software Applications for 21 CFR Part 11

    Cloud Software Applications for 21 CFR Part 11

    Training and Teaching Fremont (California) June 15, 2018 290.00 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...

  • When to Submit a 510(k) for a Change to an Existing Device

    When to Submit a 510(k) for a Change to an Existing Device

    Training and Teaching Fremont (California) June 15, 2018 290.00 Dollar US$

    Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) Why should you Attend: This presentation uses the latest FDA thinking and guidance documen...

  • Spreadsheets for 21 CFR 11 Compliance 2018

    Spreadsheets for 21 CFR 11 Compliance 2018

    Training and Teaching Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. Areas Cov...

  • Best Practices to Support FDA Computer System Validation

    Best Practices to Support FDA Computer System Validation

    Training and Teaching Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: We will cover the importance of maintaining the documentation from every computer system validation effort in a "current" state. The system must be maintained in a validated state throughout its entire life cycle, and the accompanying valid...