Best Practices for Investigating Quality Deviations

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Learn about the Best Practices for Investigating Quality Deviations that will help you manage any audits that come your way.

The COVID-19 pandemic has left a growing backlog of delayed inspections in its wake, and the FDA is prepared to hire additional employees and significantly increase the rate of inspections to compensate. That means an increased likelihood of your organization facing an audit, and increased importance in having an effective strategy for investigating quality deviations.

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


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.


About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

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