Training and Teaching

Listings
  • 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...

  • Historical Perspective of the Part 11 Regulation

    Historical Perspective of the Part 11 Regulation

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

    Overview: This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records requirements, and electronic signatures requirements. Why should you Attend: Documented Par...

  • Project Management for Non-Project Managers 2018

    Project Management for Non-Project Managers 2018

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

    Overview: This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the sub...

  • What Sponsors Expect and How to Meet their Expectations

    What Sponsors Expect and How to Meet their Expectations

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place fo...

  • How to Conduct Effective Close out Meetings

    How to Conduct Effective Close out Meetings

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your ex...

  • Why Organizations need to use CAPA, What is its Purpose?

    Why Organizations need to use CAPA, What is its Purpose?

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: In this webinar, we will review CAPA as part of Quality Management System (QMS), reasons why organizations need to use CAPA, what is its purpose. We will describe CAPA concepts and procedures. We will also describe FDA investigation procedu...