Quality Control, Safety & Security

Listings
  • Inhalation Toxicology

    Inhalation Toxicology

    Quality Control, Safety & Security (New York ) May 22, 2018 Check with publisher

    At Creative Animodel, we can conduct inhalation toxicity studies in accordance with international guidelines for regulatory agencies such as FDA, EPA, OECD, and others. By right of rich experience on inhalation studies, our team can provide comprehen...

  • 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...

  • 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...

  • 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 ...

  • 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...

  • 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...

  • Statistical Process Control & Process Capability – GlobalCompliancePanel 2016

    Statistical Process Control & Process Capability – GlobalCompliancePanel 2016

    Quality Control, Safety & Security Baltimore (Maryland) October 26, 2016 Free

    Overview: This course teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be ex...

  • Design Verification data and Process Validation 2016

    Design Verification data and Process Validation 2016

    Quality Control, Safety & Security Houston (Texas) October 26, 2016 Free

    Overview: This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The entire 2nd day is spent on Statistical Process Control and Process Capability Indices. Th...

  • NIST Cybersecurity Framework For Computer Systems Validation

    NIST Cybersecurity Framework For Computer Systems Validation

    Quality Control, Safety & Security Fremont (California) August 14, 2017 Free

    Overview: Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal informatio...

  • Clinical Data Systems Regulated by FDA

    Clinical Data Systems Regulated by FDA

    Quality Control, Safety & Security Fremont (California) November 27, 2017 Free

    Overview: Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regul...

  • Products Used in Early Phase IND Studies

    Products Used in Early Phase IND Studies

    Quality Control, Safety & Security Fremont (California) November 27, 2017 Free

    Overview: How it may be integrated with the recommendations of the guidance documents on CMC requirements. Areas Covered in the Session: Discussion of the elements found in the guidance document for Phase 1 material What to do at really early stages ...

  • What is the Purpose of a Quality Management System Seminar 2018

    What is the Purpose of a Quality Management System Seminar 2018

    Quality Control, Safety & Security Baltimore (Maryland) March 6, 2018 1.00 Dollar US$

    Overview: Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and develo...