Quality Control, Safety & Security

Listings
  • 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...

  • That your Supplier can meet all your Expectations

    That your Supplier can meet all your Expectations

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

    Overview: These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit the operation. Why should you Atten...

  • Record Keeping Best Practices [FDA and EMA] Documentation

    Record Keeping Best Practices [FDA and EMA] Documentation

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

    Overview: Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses tha...

  • 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...

  • 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...

  • 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 ...