Quality Control, Safety & Security

Listings
  • Risk Based Incident Management and [CAPA for GxP] Operations

    Risk Based Incident Management and [CAPA for GxP] Operations

    Quality Control, Safety & Security Fremont (California) November 13, 2018 290.00 Dollar US$

    Overview: This Webinar specifically addresses the Incident Management and CAPA processes of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant pr...

  • Things To Do Immediately About Master Validation Plan 2019

    Things To Do Immediately About Master Validation Plan 2019

    Quality Control, Safety & Security Fremont (California) November 13, 2018 290.00 Dollar US$

    Overview: How to develop or improve upon a Master Verification and Validation Plan and System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements. Why should you Attend: The billions of dollars spent by industry annual...

  • Take Advantage Of 21 Cfr Part 11 - Read [Immediately] These Tips

    Take Advantage Of 21 Cfr Part 11 - Read [Immediately] These Tips

    Quality Control, Safety & Security Fremont (California) November 13, 2018 290.00 Dollar US$

    Overview: These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment. Why should you Attend: CSV enables the level and r...

  • The Next Few Things To [Immediately] Do About Excel Pivot Tables

    The Next Few Things To [Immediately] Do About Excel Pivot Tables

    Quality Control, Safety & Security Fremont (California) November 13, 2018 Free

    Overview: You will also learn how to create a pivot table from multiple tables and multiple data sources, including linking to external data. Why should you Attend: Excel has a variety of tools like sorting, filtering, and subtotal to manage large li...

  • Introduction to Adaptive Design for Clinical Trials

    Introduction to Adaptive Design for Clinical Trials

    Quality Control, Safety & Security Philadelphia (Pennsylvania) October 25, 2018 1495.00 Dollar US$

    Description: This 2-day seminar includes an overview of Adaptive Design, and an emphasis in group sequential design, sample size re-estimation, and Phase II/III Adaptive Seamless Designs. The role of statistics in clinical trials incorporates the too...

  • Handling Situations Where Regulation (E and ACH) Don't Align

    Handling Situations Where Regulation (E and ACH) Don't Align

    Quality Control, Safety & Security Fremont (California) October 11, 2018 Free

    Overview: This training program will review intent and focus of Regulation E and the ACH Rules.It will analyze situations where Regulation E and the ACH Rules do not align and help determine appropriate responses and procedures to manage risk and los...

  • Compliance with 21 CFR Part 11 (Data Integrity)

    Compliance with 21 CFR Part 11 (Data Integrity)

    Quality Control, Safety & Security Fremont (California) October 11, 2018 Free

    Overview: It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). Areas Covered in the Session: What 21 CFR Part 11 means today Purpose of Part 11 What does Part 11 mean? SOPs System feature...

  • Vendor-CRO-CMO Oversight in the (Biopharma) and Device Industry

    Vendor-CRO-CMO Oversight in the (Biopharma) and Device Industry

    Quality Control, Safety & Security Fremont (California) October 11, 2018 Free

    Overview: This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device ...

  • Statistical Quality Control in Pharmaceutical and (IVD Industries)

    Statistical Quality Control in Pharmaceutical and (IVD Industries)

    Quality Control, Safety & Security Fremont (California) October 11, 2018 Free

    Overview: Process validation is the establishment of documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre- determined specifications and quality characteristics. Are...

  • Guidance on How to (Justify) such Sample Sizes

    Guidance on How to (Justify) such Sample Sizes

    Quality Control, Safety & Security Fremont (California) October 11, 2018 Free

    Overview: This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size. Areas Cov...

  • Control-Analysis Instrumentation used in PAT Continuous [Manufacturing]

    Control-Analysis Instrumentation used in PAT Continuous [Manufacturing]

    Quality Control, Safety & Security Fremont (California) September 12, 2018 150.00 Dollar US$

    Overview: How to build the PAT/CM team and set goals, budgets, and make the change-overs smoothly and efficiently. Why should you Attend: This course will show the tools used in PAT, QbD, and CM, what they "do and see" and what they bring to the effo...

  • Which are Compliant for Inspections for a [GXP Compliance]

    Which are Compliant for Inspections for a [GXP Compliance]

    Quality Control, Safety & Security Fremont (California) September 12, 2018 150.00 Dollar US$

    Overview: This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements. Why should you Attend: This webinar will assist you to prepare for inspection of SOPs, particularly...