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Implement Quality Metrics and Achieve Quality Systems Excellence

February 27-March 1, 2018
  • San Diego, CA

IVT’s Quality Risk Management & Change Control event is the industry’s leading forum for integrating quality metrics into validation systems, developing effective risk management strategies and implementing enterprise-wide change control programs.

Convene with Quality and Validation counterparts to break down FDA’s CDER and CBER Quality Metrics draft guidance, ensure ICH Q10 and ICH Q9 compliance, conduct risk-based impact assessments, and streamline change control strategies.

Gain Insight from Leaders in Pharmaceutical Quality on Critical Topics, Including:

  • Requirements and strategies for the pharmaceutical quality system
  • CAPA implementation to adhere to Quality Metrics initiatives
  • SPC as a tool for understanding and managing variability
  • Integrating change control and risk management into
    manufacturing controls validation and state of control
  • Risk-based impact assessments
  • Execution of QRM for existing running facility before publishing
    the guidelines and documents requirements
  • Application of less formal tools in risk management

Download the Agenda at a Glance

Previous CBI Attendee Acclaim:

I have attended numerous change control conferences
and training events of various professional organizations.
This is hands down the best. The take-away tools and
information will be most beneficial.

Validation Manager, Sigm Tau Pharma

The information that I got at IVT’s conference is very useful to me. My manager is going to ask, Why did I send you to this conference? and I have an answer. Basically, I am going to be the FDA auditor in the analytical department. Knowledge is power.

Analytical Chemist, Alphora Research Inc.

Excellent speakers and up-to-date presentation content — very informative and useful!

QA, Bayer Consumer Health

Great forum to network with industry professionals and to get input on the latest updates on FDA initiatives.

Associate Director, Quality System Analytics, Alexion Pharmaceuticals

Quality Risk Management & Change Control

Implement Quality Metrics and Achieve Quality Systems Excellence

IVT’s Quality Risk Management & Change Control event is the industry’s leading forum for integrating quality metrics into validation systems, developing effective risk management strategies and implementing enterprise-wide change control programs.

Convene with Quality and Validation counterparts to break down FDA’s CDER and CBER Quality Metrics draft guidance, ensure ICH Q10 and ICH Q9 compliance, conduct risk-based impact assessments, and streamline change control strategies.

Gain Insight from Leaders in Pharmaceutical Quality on Critical Topics, Including:

  • Requirements and strategies for the pharmaceutical quality system
  • CAPA implementation to adhere to Quality Metrics initiatives
  • SPC as a tool for understanding and managing variability
  • Integrating change control and risk management into
    manufacturing controls validation and state of control
  • Risk-based impact assessments
  • Execution of QRM for existing running facility before publishing
    the guidelines and documents requirements
  • Application of less formal tools in risk management

Download the Agenda at a Glance

Previous CBI Attendee Acclaim:

I have attended numerous change control conferences
and training events of various professional organizations.
This is hands down the best. The take-away tools and
information will be most beneficial.

Validation Manager, Sigm Tau Pharma

The information that I got at IVT’s conference is very useful to me. My manager is going to ask, Why did I send you to this conference? and I have an answer. Basically, I am going to be the FDA auditor in the analytical department. Knowledge is power.

Analytical Chemist, Alphora Research Inc.

Excellent speakers and up-to-date presentation content — very informative and useful!

QA, Bayer Consumer Health

Great forum to network with industry professionals and to get input on the latest updates on FDA initiatives.

Associate Director, Quality System Analytics, Alexion Pharmaceuticals