2023 PDA Mastering Deviations Workshop

Washington, DC
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Program Highlights

New Name, Same Great Content

Formerly the 2023 PDA Deviation Writing Workshop, we changed the name of this event to emphasize the level of expertise and proficiency that you will gain through participation. We look forward to welcoming you to this reimagined event that will leave a lasting impact on your professional journey!

There is a failure to thoroughly investigate unexplained discrepancies…

Has your organization received this feedback in an FDA Form 483? If yes, get expert advice to further develop deviation writing and investigation skills at the 2023 PDA Mastering Deviations Workshop!

In this workshop, participants will learn how to:

  • write effective deviation reports that meet regulatory requirements;
  • develop a defined process for classifying deviations, and learn how to develop of a compelling story (yes, deviations are storytelling!);
  • develop a toolkit for investigators; and,
  • accelerate investigations from start to finish.


  • Tita Tavares, PDA (Chair)
  • Frederic Ayers, Valsource, Inc.
  • Julie Barnhill, Meridian BioGroup - Pace Life Sciences
  • Jamie Bastien, Bristol Myers Squibb
  • Gerardo Gomez, PharmaLex
  • Martin Jenkins, Circle MJ Consulting
  • Kate Malachowski, Novavax
  • Katie Masterson, REGENXBIO
  • Megan Matthews, Emergent BioSolutions

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1


07:45 – 17:30 | Registration Open

07:45 – 08:45 | Continental Breakfast

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.

08:45 | Opening Remarks from Workshop Chair
Tita Tavares,
Chief of Staff, PDA

08:55 | Regulator Remarks
Carmelo Rosa, PsyD, 
Division Director, Office of Manufacturing and Product Quality, OC, CDER, U.S. FDA

09:10 | The Case for Storytelling
Tosin Akinyinka, MS, Senior Bioprocess Engineer, Novavax

09:30 | The Nuts and Bolts of Storytelling
Kim Rice, MS,
Senior Consultant, Process Alliance LLC

09:50 | Hands-On Activity: Deviation Storytelling

10:10 | Q&A

10:30 – 11:00 | Networking Break in the Exhibit Area

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.

11:00 | Deviation Categorization for Large-Scale Commercial Manufacturing
Chuck Bornhoeft, MS,
Vice President - Quality Operations, Rion

11:20 | The Importance of Deviation Categorization for Investigations
Anne McKenna, MSc,
Head of Investigation Management – Global Quality and Compliance, Takeda

11:40 | Hands-On Activity: Deviation Categorization

12:00 | Q&A

12:30 – 13:30 | Networking Lunch in the Exhibit Area

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.

13:30 | Pedal to the Metal: Just-in-Time for Release
Julie Barnhill, PhD,
Senior Consultant, Pace Life Sciences

14:00 | Digging Out of the Backlog: Ways to Get It Done
Megan Matthews, MS,
Production Compliance Manager, Emergent BioSolutions

14:30 | Q&A

15:00 – 15:30 | Networking Break in the Exhibit Area

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.

15:30 | Writing Readable Deviations Records
Karl Keller, MBA,
Principal, Communication Partners

16:10 | Hands-On Activity: Role Play

16:30 | Q&A

17:00 – 18:00 | Networking Reception in the Exhibit Area

Day 2


08:00 – 13:15 | Registration Open

08:00 – 09:00 | Continental Breakfast

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!

09:00 | Maximizing Your Inventory of Diplomacy Tools
Michael Murry,
Regulatory Compliance & QMS Manager, Plexus Corp.
Abby Rutman, Operations Manager, Azzur Group

09:30 | Managing Expectations with Stakeholders
Jamie Bastien,
Quality Operations Manager, Bristol Myers Squibb

10:00 | Q&A

10:30 – 11:00 | Networking Break in the Exhibit Area

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?"

11:00 | Core Concepts for Every Deviation Report
Simone Ammons, MS,
Principal, QuneUp™, Eluciniere

11:30 | Q&A with Additional Panelists
Karl Keller, MBA,
Principal, Communication Partners
Kim Rice, MS, Senior Consultant, Process Alliance LLC
Michael Murry, Regulatory Compliance & QMS Manager, Plexus Corp.
Tita Tavares, Chief of Staff, PDA
LT Seneca D. Toms, MS, MSEH, RAC, National Expert, Drugs, OMPTO, ORA, U.S. FDA 

12:30 | Closing Remarks from Workshop Chair

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA Mastering Deviations Workshop!

The Workshop hotel room block is closed. We recommend calling the Renaissance for reservations or booking online for the best available rate.


Phone: +1 (202) 898-9000
Click on the reservation link above

Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. From museums to entertainment, this is the perfect base for exploring downtown DC. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi. Steps from shopping, dining, nightlife and sports, this hotel places the best of DC at your doorstep. Expect the extraordinary at Renaissance Washington, DC Downtown Hotel.
How to Get Here
By Air The airports closest to the Renaissance Washington, DC Downtown hotel are Reagan National Airport (DCA, 4.6m/7.4km), Dulles International Airport (IAD, 27.8m/46.2km), and Baltimore-Washington International Airport (BWI, 32.1m/51.7km).
By Car The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($35+/day) and valet parking ($61+/day) are available.