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PDA 257 Risk-Based Approaches to Achieve Effective Training and Holistic CCS Success

Sep 21, 2023
Washington, DC

  • Education
  • The Americas


LOGO-Innerspace PDA Partnership

Health authorities and guidelines suggest that a holistic CCS to ensuring safety in manufacturing processes is essential, which should be based on differentiated data and proper risk assessment. This means that a risk-based approach to the fundamentals of aseptic processing, as well as specific processes, is critical to developing effective training and standard operating procedures (SOPs).

This training course is divided into four parts:

  • The first part focuses on how to create a risk-based training approach for fundamentals of aseptic processing. Examples are provided to illustrate how risk-based learning objectives can be developed and used to guide curriculum design and assessment/qualification programs for cleanroom operators. Participants will also get hands-on experience with a Virtual Reality Cleanroom Simulator.
  • The second part introduces “Frame-by-Frame Risk Profiling” as a novel approach to identify possible errors within specific aseptic manufacturing processes. Participants will learn how the "process frame library" was used in previous projects to categorize and understand specific risks in aseptic manufacturing.
  • The third part of the training course focuses on using risk profile data to develop effective training exercises and SOPs for specific processes, with the goal of improving operator training and risk management.
  • The final part of the training course shows how the risk profile-based approach can be used to provide a compelling rationale to health authorities for staff training and SOPs as part of a holistic CCS.
For more options and/or related training courses, please visit the page(s) below.

PDA Quality Risk Management Training Courses
PDA Regulatory Training Courses


  • Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast and lunch will be provided.


Sebastian Scheler
Sebastian Scheler
Innerspace GmbH

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Understand risk-based approaches for training and qualification in aseptic manufacturing
    2. Develop risk-based training objectives and exercises (including VR Simulator) for fundamentals of aseptic processing
    3. Understand how to use Frame-by-Frame Risk Profiling to identify process-specific risks and develop tailored training and SOPs
    4. Be able to define criteria for risk-based SOPs and training documents
    5. Understand how to use the risk profile-based approach to develop a compelling CCS-rationale to health authorities for operator training in aseptic manufacturing
  • Who Should Attend

    This training course is intended for professionals who are interested in a risk-based approach to developing effective training and SOPs and how to apply them pragmatically to their manufacturing facilities using state of the art simulator technology.

    Manufacturing, Quality Assurance Operations, Training

    Supervisor, Manager, Director, Auditor/Inspector, Trainer

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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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  • Accommodations
    The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA/FDA Joint Regulatory Conference!

    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


    Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
    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 for fare and schedule information.


Registration Fees

Early Registration
Registration Type Price By August 7, 2023
Member $899
Non-member $1,079
Gov't/Health Auth./Academic $699

Regular Registration
Registration Type Price After August 7, 2023
Member $999
Non-member $1,199
Gov't/Health Auth./Academic $699

* For this member type or discount, online registration is not available, please contact [email protected].

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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