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2023 Deviation Writing

2023 PDA Deviation Writing Workshop

Sep 21 - Sep 22, 2023
Washington, DC

Investigations: Telling the Complete Story

  • Workshop
  • The Americas
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Program Highlights

Early registration is going on now until 23 July, with up to $500 in savings!

Overview

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 skills at the 2023 PDA Deviation Writing Workshop!

In this workshop, participants will learn how to:

  • write effective deviation reports that meet reglatory 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.
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Agenda

  • Day 1
  • Day 2

  • THURSDAY, 21 SEPTEMBER

    08:00 – 17:30 | Registration Open

    08:00 – 09:00 | Continental Breakfast

    09:00 – 10:30 | P1: Categorizing the Level of Deviation
    Moderator: Frederic B. Ayers, Advisor - Sterility Assurance, Global Parenteral Products Network, Eli Lilly and Company

    Deviation management requires identifying, assessing, and correcting deviations from approved instructions or established standards. How do we consistently categorize deviations upon identification? Can a deviation categorization be modified prior to closure? These are just a few questions that will be explored during this engaging session. Presentations will discuss defined processes and criteria for classifying deviations to ensure commensurate levels of investigation are performed. Attendees will then have a table activity to practice the categorization of deviations followed by a Q&A session. 

    09:00 | Opening Remarks from Workshop Chair
    Tita Tavares,     Director, Azzur Group

    09:10 | Industry Representative Invited

    09:30 | Industry Representative Invited

    09:50 | Hands-On Activity: Deviation Categorization

    10:10 | Q&A

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

    11:00 – 12:30 | P2: Telling a Compelling Story: From Root Cause to Resolution 
    Moderator: Kate Malachowski, PhD, Associate Director, MS&T, Novavax

    In this dynamic and interactive session, participants 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). During the session, the 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, participants will be guided through the process of creating a thorough and impactful deviation write-up with a right-sized level of detail and effort.

    11:00 | Tosin Akinyinka, Senior Bioprocess Engineer, Novavax

    11:20 | Industry Representative Invited 

    11:40 | Hands-On Activity: Deviation Storytelling

    12:00 | Q&A

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

    13:30 – 15:00 | P3: Accelerating Investigations from Start to Finish 
    Moderator: Tita Tavares, Director, Azzur Group

    In this session, participants will gain comprehensive knowledge and practical strategies to rapidly streamline the investigation and resolution process for deviations. The presenters will guide participants through each stage, from facilitating investigations and authoring well-structured reports to implementing practical corrective actions to minimize downtime and ensure efficient deviation management from start to finish.   

    Throughout the session, participants will engage in interactive discussions, case studies, and practical exercises to reinforce their understanding of the accelerated quality deviation process. They will be equipped with valuable tools, techniques, and insights to enhance their ability to effectively manage and resolve quality deviations, improving operational efficiency and product quality. 

    13:30 | Julie Barnhill, Senior Consultant, Meridian BioGroup – Pace Life Sciences 

    14:00 | Industry Representative Invited

    14:30 | Q&A

    15:00 – 15:30 | Networking Break

    15:30 – 17:00 | P4: Technical Writing 
    Moderator: Gerardo Gomez, 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 | Industry Representative Invited

    15:50 | Industry Representative Invited 

    16:10 | Hands-On Activity: Role Play

    16:30 | Q&A

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

  • FRIDAY, 22 SEPTEMBER

    08:00 – 13:15 | Registration Open

    08:00 – 09:00 | Continental Breakfast

    09:00 – 10:30 | P5: The Investigator’s Tool Kit
    Moderator: Julie Barnhill, PhD, Senior Consultant, Pace Labs

    Investigators play a crucial role in identifying, investigating, and documenting deviations. This interactive session will focus on equipping investigators with the knowledge and skills to utilize various tools effectively during the deviation management process to identify root causes and remediate issues appropriately. Participants will gain the knowledge and skills to select, implement, and employ tools effectively, ensuring efficient and thorough investigations, including the use of fishbone diagrams, 5-why analysis, fault tree analysis, failure modes and effect analysis (FMEA), Pareto charts, and scatter plots. In addition, this session will address how to use other tools to best manage the deviation process from start to finish including Track Wise, OneNote, and SharePoint, and will also illustrate how to develop and leverage a detailed checklist during the investigation and deviation writing process to ensure consistently complete and well-written deviations.

    09:00 | Industry Representative Invited

    09:30 | Industry Representative Invited 

    10:00 | Q&A

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

    11:00 – 12:45 | P6: Workshop Wrap Up
    Moderator: Martin Jenkins, Director of CQV, PM Group, LLC

    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.

    The workshop will close with an interactive panel discussion focusing on lessons learned, training recommendations, and “what comes next?”

    11:00 | Simone Ammons, Principal, QuneUp, and Eluciniere

    11:30 | Panel Discussion and Q&A

    12:30 | Closing Remarks from Workshop Chair
    Tita Tavares,     Director, Azzur Group

Networking Opportunities

THURSDAY, 21 SEPTEMBER

  • 10:30 – 11:00 | Networking Break in the Exhibit Area
  • 12:30 – 13:30 | Networking Lunch in the Exhibit Area
  • 15:00 – 15:30 | Networking Break in the Exhibit Area
  • 17:00 – 18:00 | Networking Reception in the Exhibit Area

FRIDAY, 22 SEPTEMBER

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

Additional Information

  • Who Should Attend

    More information coming soon.

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Travel

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.

Renaissance Washington, DC Downtown

999 9th Street NW
Washington, DC

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Renaissance Washington, DC Downtown
 
  • Accommodations
    The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA Deviation Writing Workshop!

    Rate: $331 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 18 August 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 15:00
    Check-Out: 12:00

    Reservations

    Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
    Online:     Click on the reservation link above

    Individual Cancellation

    All cancellations must be received by 23:59 local time 72-hours before arrival to avoid a penalty of one night room and tax. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities
    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.

Other Options

The metro stations closest to the Renaissance Washington, DC Downtown hotel are Mount Vernon Square (yellow/green line, 0.4m/0.6km), Gallery Place (red/yellow/green, 0.3m/0.5km), and Metro Center (red/blue/orange/silver, 0.4m/0.6km). Please visit www.wmata.com for fare and schedule information.

Directions

Registration Fees

Early Registration
Registration Type By 23 July
Member $1,595
Non-Member $1,995
Gov./Health Authority/Academic (Member Only) $795
Student (Member Only) $495
Early Career Professional (Member Only) $1,295
Regular Registration
Registration Type After 23 July
Member $2,095
Non-Member $2,495
Gov./Health Authority/Academic (Member Only) $895
Student (Member Only) $595
Early Career Professional (Member Only) $1,395

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].

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