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  • 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...

  • 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 ...

  • Revolutionary Change in FDA Software Regulation

    Revolutionary Change in FDA Software Regulation

    Clinical Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software regulation needs to ease up and reap the benefits where they apply. Your company may even s...

  • When Conducting cGMP Regulatory Inspections 2018

    When Conducting cGMP Regulatory Inspections 2018

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

    Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA,...

  • 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...

  • Design Control is Critical to Product Quality

    Design Control is Critical to Product Quality

    Chemical Methods Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. Why should you Attend: Design C...

  • 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...