PDA Letter Article

Maintaining Compliance with Deviation Reports: A Glimpse into the 2023 PDA Mastering Deviations Workshop

by Kate Malachowski, Novavax

Deviation reports play a critical role in maintaining compliance with regulatory bodies and health authorities. These reports provide a transparent account of deviation events and demonstrate a strong quality culture and adherence to regulatory guidelines. Writing a comprehensive report ensures that the root cause analysis is captured accurately for future reference and continuous improvement. Despite a broad understanding of the benefits and requirements for thorough deviation reports, poor investigations of discrepancies and failures rank high among the most common 483 observations.

Defining the requirements to meet the regulatory standard of a thorough investigation can be tricky, starting with categorizing the deviation. While decision trees can help, companies often struggle to consistently apply the right criteria to deviation categorization and to right-size their level of effort. Basic root cause analysis tools, such as fishbone diagrams and “Five Whys," are commonly used to move through an investigation. Still, converting the information in those tools into a compelling narrative is difficult to teach and capture in a standard operating procedure. Reports with too much data and information can introduce data integrity risks and elicit additional questions during audits. Reports with too little information or an unclear link to the root cause conclusion or CAPA risk an audit observation.

It can be even harder to meet the standard of quality if an organization is dealing with competing priorities, a backlog of deviations, or a tight business timeline for batch release. With these challenges in mind, PDA and our program committee will bring together professionals with expertise in deviation writing at the 2023 PDA Mastering Deviations Workshop for a two-day workshop in Washington, D.C., September 21-22.

As Watson did for Sherlock, the workshop will share strategies on getting pen to paper to capture the narrative of an investigation and lead readers and auditors from root cause to resolution. With a highly interactive approach to each session, hands-on exercises and resources to take home, this workshop offers valuable insights into deviation categorization, strategies for accelerating deviation reports and right-sizing efforts, an investigator’s toolkit to help manage investigations and deviation writing, technical writing dos and don’ts, and a glimpse into the future of deviation writing.

We hope to see you there!

About the Author

Kate MalachowskiKate Malachowski, PhD, is an Associate Director of Manufacturing Science and Technology (MS&T) at Novavax. She leads a team of scientists and engineers to support Novavax's global drug substance manufacturing operations, data trending and CPV programs. She has also previously worked at Catalent, supporting gene therapy projects and with the BioPhorum Extractables and Leachables work group. Moreover, Kate served on the 2023 PDA Annual Meeting Planning Committee. Before entering the space of biotech, she worked in microscale medical and semiconductor devices at the Army Research Laboratory and Northrop Grumman. Kate holds a bachelor’s degree in chemical engineering from Virginia Tech and a doctorate in chemical and biomolecular engineering from Johns Hopkins University.