Practical Approach to Using Quality Risk Management Principles

Current good manufacturing practices (cGMP) is to ensure that products are consistently produced and controlled according to quality standards.

Validation is defined as the establishing of documented evidence which provides a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes.

This training will address a practical approach to using Quality Risk Management principles to support risk based qualification, validation programs, and change control proposals using a scientific approach.

  • The importance of user requirement specification
  • Validation Master Plan-what to include
  • Qualification and validation steps
  • Common mistakes made during validation

Instructor

Ziva Abraham

Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi towards her Ph.D degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination
should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.

Date

December 8, 2020
12 - 1 p.m. Central Time
Virtual
 

Registration Information

Member :$49
Non-member: $79

Online registration closes December 2

Register three attendees from your company for the same training course and receive a complimentary fourth registration for another person in your company to attend that course for free! Contact IEST at 847-981-0100 to arrange this option. (Complimentary registration applies to registration of equal or lesser value. Not valid with any other offers or promotions.)

  • Transfers: All registrations are transferable to another person for the same event A $35 transfer fee applies. Transfer of a member registration to a nonmember registration will be charged the difference in fees.
  • Cancellations: Cancellation requests received 60 days or more prior to the start of the event will receive a full refund LESS a $75 administration fee. Cancellation requests received 30-59 days prior to the start of the event will receive a 50% refund. No refunds will be issued for cancellation requests received less than 30 days prior to the start of the event. IEST reserves the right to cancel course(s), in which case registrants will receive a refund of the fee. IEST is not responsible for any refund or remuneration for hotel, transportation, additional registration fees, tours, or other expenses related to attendance beyond the registration fee refund.
  • IEST reserves the right to cancel courses, in which case registrants will receive a full refund of the tuition fee.
  • Program and instructor(s) are subject to change.
  • .1 CEUs per class.
  • Payment must accompany registration; there is no invoicing. IEST does not accept purchase orders as a method of payment.
  • All member dues must be current at the time of registration to qualify for the member rates.
  • All education training courses earn Continuing Education Units.