Quality Control, Safety & Security

Listings
  • FDA New Draft Guidance on (Software) and Device Changes 510k

    FDA New Draft Guidance on (Software) and Device Changes 510k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 ...

  • Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Compliance for Electronic Records and Signatures (21 CFR Part 11)

    Quality Control, Safety & Security Fremont (California) July 11, 2018 150.00 Dollar US$

    Overview: Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, an...

  • Strategies for Improving Effectiveness and Efficiency of your Quality Management System

    Strategies for Improving Effectiveness and Efficiency of your Quality Management System

    Quality Control, Safety & Security Boston (Massachusetts) July 5, 2018 1295.00 Dollar US$

    This two-day seminar will cover the essentials of an effective yet efficient Quality management system for medical device companies. An efficient and effective Quality System can be a competitive advantage for companies by leading to improved Quality...

  • 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 ...

  • 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,...

  • 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...

  • Fundamentals of Risk Management in Clinical Research 2018

    Fundamentals of Risk Management in Clinical Research 2018

    Quality Control, Safety & Security Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at th...

  • Course on GxP/GMP Regulations: Requirements Compliance 2018

    Course on GxP/GMP Regulations: Requirements Compliance 2018

    Quality Control, Safety & Security San Diego (California) March 6, 2018 1295.00 Dollar US$

    Overview: GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of produc...

  • Statistical Sampling Plans - Seminar 2018 Methods and Applications

    Statistical Sampling Plans - Seminar 2018 Methods and Applications

    Quality Control, Safety & Security Seattle (Washington) March 6, 2018 1.00 Dollar US$

    Overview: Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this rich field of techniques is not as prominent as it once had been....