PDA CCS: Controlling Personnel and Material Risks in Cleanrooms Workshop 2025
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Kelly Waldron, PhD
ValSource, Inc.
Business Unit Manager, Quality and Manufacturing Science Consulting
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Agenda
Discover What's Happening Each Day
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AEDT Daylight Time (UTC +11:00)
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Registration
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Session 1
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Welcome to the workshop and overview of Contamination Control Strategy (CCS) expectations
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Challenges faced by industry - Warning letters and a US perspective
This seminar will cover recent regulatory and guidance updates on cleaning and disinfection and contamination control in cleanrooms. Current FDA Warning Letters and 483’s will be discussed related to cleaning and disinfection, materials transfer, and contamination control. Recent updates from the new Annex I, PDA’s Technical Report #70 as well as USP General Chapter <1072> will all be reviewed with an interactive exchange with attendees.
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Challenges faced by industry - an Annex 1 author and ex-MHRA inspectors perspective
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PDA/ANSI (Standard 03-2025): Standard Practice for Quality Risk Management of Aseptic Processes - another tool for your QRM toolbox
This session will provide an overview of the key concepts from the recent PDA/ANSI standard 03-2025, “Quality Risk Management for Aseptic Processing.” The standard provides an approach to conduct a risk assessment to inform the contamination control strategy (CCS), including (but not exclusive to) that for product produced by aseptic processing.
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Coffee Break
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Session 2
Evaluating and controlling potential contamination risks posed by personnel and their movements throughout cleanrooms and facilities.-
Overview of personnel contamination risks and case study scenario for the workshop exercise
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Workshop Exercise - Contamination Control Strategies for personnel in cleanrooms and facilities
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Discussion on personnel workshop exercise outcomes
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Presentation on personnel risks and control strategies
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Lunch Break
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Session 3
Assessing and controlling contamination risks posed by materials and equipment as they move from the warehouse to the most critical zone (Grade A).-
Overview of material and equipment contamination risks and case study scenario for the workshop exercise
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Workshop Exercise - Contamination Control Strategies for material and equipment transfer in cleanrooms and facilities
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Discussion on material and equipment workshop exercise outcomes
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Presentation on material and equipment risks and control strategies
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Coffee Break
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Session 4
Cleaning and Disinfection, an essential element of any Contamination Control Strategy.-
Overview of Cleaning and Disinfection as a Contamination Control Strategy and case study scenario for the workshop exercise
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Workshop Exercise - Cleaning and Disinfection Contamination Control Strategies
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Discussion on cleaning and disinfection workshop exercise outcomes
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Case Study
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Final Q&A Discussion
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Closing Remarks
Location and Travel
Venue Details and Accommodations
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.
Pullman on the Park
192 Wellington Parade, East Melbourne VIC 3002, AustraliaMelbourne, Australia
+61 (03) 9419 2000
Reservation Instructions
PDA secured preferential rates for our delegates at Pullman Melbourne On The Park during the conference. To book a room at the hotel, please use the link below before 8 October.
Room Rate for Superior Rooms
Single Room at AUD 299 per night
- Excludes breakfast and inclusive of tax
Single Room at AUD 341 per night
Includes breakfast and inclusive of tax
Registration
Pricing Options
Standard Registration
Member Price
USD 499 / AUD 799Non-Member
USD 499 / AUD 799
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