2023 PDA Mastering Deviations Workshop

08:45 – 10:30 | P1: How to Tell a Compelling Story: From Root Cause to Resolution
Moderator: Kate Malachowski, PhD, Associate Director, MS&T, Novavax

Make sure your story is effectively told! In this dynamic and interactive session, you will learn the art of crafting a compelling deviation narrative to effectively communicate the logical path through root cause analysis (RCA) to resolution and corrective and preventative actions (CAPA). Presenters will delve into the key components of a powerful root cause narrative and explore techniques to convert RCA tools, data, and hypotheses into a well-written deviation. Drawing from real-world examples and best practices, presenters will guide you through the process of creating a thorough and impactful deviation write-up with a right-sized level of detail and effort.

11:00 – 12:30 | P2: Categorizing the Level of Deviation
Moderator: Frederic B. Ayers, Senior Consultant, ValSource, Inc.

Deviation management requires identifying, assessing, and correcting deviations from approved instructions or established standards, but how do we consistently categorize deviations upon identification? And, can a deviation categorization be modified prior to closure?

These are just a few of the important questions that will be explored during this engaging session. Hear directly from the experts about defined processes and criteria for classifying deviations to ensure commensurate levels of investigation are performed. Then take part in an interactive table activity to practice the categorization of deviations, followed Q&A.

13:30 – 15:00 | P3: Accelerate Investigations from Start to Finish
Moderator: Tita Tavares, Chief of Staff, PDA

In a fast-paced business environment, the ability to expedite deviations and ensure timely lot release is essential for success. It is also critical to know how to approach a backlog of unresolved deviations which can not only be a signal of a poor-quality culture but can leave an organization subject to high quality and compliance risks. This immersive session is designed to equip participants with the knowledge, strategies, and tools needed to effectively manage and expedite deviations, ensuring timely lot releases, while ensuring high-quality standards are maintained. By mastering techniques for faster science-based compliant resolutions and streamlined processes, attendees will learn how to navigate deviations efficiently from start to finish.

15:30 – 17:00 | P4: Technical Writing
Moderator: Gerardo Gomez, PhD, Director, Service Line Leader for QMC-US & CQV SME, PharmaLex

In this dynamic and interactive session, participants will learn the art of crafting a component of a deviation investigation (i.e., the "scribe" role) is as important as the "analysis" component (i.e., the "Sherlock Holmes" role). In addition, participants will also explore key principles and best practices for effective technical writing applied to deviation investigations. At the end of this session, participants will be in a position to excel in their roles as Investigators, QA Reviewers, and Deviation SMEs by applying modern-day technical writing concepts, rules, and guidelines.