Webinar

Investigating Quality Deviations


The pandemic created a backlog of delayed inspections in its wake, and regulatory bodies are prepared to hire additional employees and significantly increase the rate of inspections. That means an increased likelihood of your organization facing an audit, and increased importance in having an effective strategy for quality deviation audits & investigations.

MasterControl has partnered with regulatory experts Regulatory Compliance Associates (RCA) for an exclusive virtual event exploring best practices for investigating quality deviations. Join Sue Schniepp – RCA Distinguished Fellow for an informative event designed to help you manage quality events and effectively manage any audits that come your way.

We’ll explore strategies for:

  • Audit management and how to define root cause early.
  • Why centralized workspaces are interconnected with quality.
  • CAPA processes and quality event forms.
  • Answering interview questions about standardization.
  • Organizing source documents for audit reporting
  • Quality deviation inspection best practices

 

About MasterControl

MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organisations digitise, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit www.mastercontrol.com.

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    Presenters

    Susan Schniepp

    Susan Schniepp

    RCA Distinguished Fellow

    With more than 40 years of industry experience in quality control and quality assurance, Sue has had responsibilities for complaints, labeling, investigations, compendial affairs, and other quality systems. In addition to RCA, she has held leadership roles at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott; and Hospira.

    She has served the Parenteral Drug Association (PDA) as a member of the Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of PDA's Regulatory Affairs / Quality Advisory Board. She was also awarded PDA's Distinguished Service Award in 2008.