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.

09:00 – 10:30 | P5: The Report Writer's Tool Kit
Moderator: Julie Barnhill, PhD, Senior Consultant, Pace Life Sciences

Does your strategy for authorship of deviation reports include an emphasis on how and when to apply the appropriate tools? Whether your stakeholders are internal team members or external suppliers, knowing what tools and approaches to use can make all the difference in completing your reports on-time, with clarity demonstrating the identification of the root cause, showing corrective actions have been implemented, and safety and quality of the product has been ensured.

This interactive session will dive into how to ensure the details of the report provide an appropriate level of background and ensure the level of investigation is thorough and commensurate with the level of risk. A framework for structuring investigation report management and techniques for navigating cross-functional groups will be shared and discussed. Be ready to engage and develop your own playbook!

11:00 – 12:45 | P6: Taking it Back, Moving it Forward: Key Takeaways for a Sustainable Impact
Moderator: Martin Jenkins, PMP, Senior Project Manager, Qualification and Validation, Circle MJ Consulting

How do we put it all together? This closing session will address the core elements of deviation reports, advantages, disadvantages, and risks associated with using enterprise software for deviations, and the future direction of deviation writing. Bring your unanswered questions to the interactive panel discussion, where the experts will share lessons learned, training recommendations, and their thoughts on "what comes next?"