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Registration is Now Open for ASQ Baltimore Section 0502 April 9, 2024 Virtual Member Meeting

By Cindy Walters posted 25 days ago

  

Our April 9th meeting will be held as a Virtual Meeting with both a program and tutorial.

Stacey Largent is a senior consultant at ValSource, Inc. Over the past 4.5 years, she has specialized in consulting on the following topics: quality risk

management (QRM), aseptic processing, sterility assurance, and supporting the needs of vaccine/biopharmaceutical product development and

manufacturing. In the space of QRM, Stacey facilitates complex risk assessments and develops phase-appropriate programs, role-based training

content, and customized risk assessment methodologies. She holds a B.S. in biomedical engineering from Drexel University and an M. Eng. in

biological chemical engineering from Lehigh University. With more than 20 years in the pharmaceutical and medical device industry, she spent over 16

years at Merck and most recently served as head of its global QRM Center of Excellence. Stacey also has experience in evaluating new technologies,

tech transfer, leading complex investigations, and method development.

She can be reached at slargent@valsource.com.

The program topic for the evening is "Pitfalls of Quality Risk Management and Risk Assessments"  

  • ·        Brief background on Quality Risk Management (QRM) with respect to ICH Q9(R1) – including what QRM is and is not; regulators’ expectations
  • ·        Presentation of several common pitfalls within QRM and execution of risk assessments including their impact, examples, and potential solutions

After the program, the tutorial topic is "Risk Ranking & Filtering: A Customizable Tool for Making Risk-based Decisions"

  • ·         Explain Risk Ranking & Filtering (RRF) and its benefits / limitations
  • ·         Describe the process of creating a custom RRF tool
  • ·         Share two examples of RRF tools (one real world example on home buying and one technical example

Please Note:  Advanced registration is required (link below) and will close at noon on Sunday April 7, 2024

Online Instructions:

Url:  https://asq.co1.qualtrics.com/jfe/form/SV_eqDRSSMGI0CnZIi

Login: Please use the link above to register for this event. You will receive an email form "ASQ Baltimore 0502" confirming that your registration has been processed and containing the link to join the meeting. Please note: Registration closes at noon on Sunday April 7th.

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