PDA Annex 1 Implementation: Inspection Ready Workshop 2025
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ICT Standard Time (UTC +7:00)
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Registration
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Opening Session
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Introduction by Program Chair
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Keynote: GMP for ATMPs and Challenges to Implementation
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Coffee Break
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Session 1
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Understanding PIC/s Annex 1, PIC/s Annex 2A for ATMPs and the current revision of the EC/GMP Part IV Guidelines
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Developing a Robust Contamination Control Strategy (CCS) for Compliance
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is in effect from 25th August 2023. It took almost 6 years to revise & finalise the Annex 1 Guide. In the revised Annex 1 document Contamination Control Strategy (CCS) has been emphasised multiple times. PDA through its TR 90 also brought up CCS strategy development in Pharmaceutical Manufacturing in 2023.In this session, we will bring to you on how selection of Raw Materials & Consumables like Filters & Single Use enables you to achieve Contamination Control. When you implement SU Technologies, does it lead you onto the path of Closed Processing? The session will also focus on the new sections that are added & sections that are modified in Annex 1 which impacts Sterile Filtration.
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Session 2
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Cleanroom Design and Environmental Monitoring: Meeting Annex 1 Standards
The revised Annex 1 in PIC/S Guide to GMP PE 009-17 focuses on building Quality Risk Management (QRM) into all activities, leading to a holistic Contamination Control Strategy which includes your Environmental Monitoring (EM). Your facility design (new or existing) plays a direct and foundational role in shaping how you perform EM, but now the EM program needs to be justified with a documented comprehensive risk assessment. What is required? What must we do to comply? It is easy to identify a risk qualitatively (is it a risk or not?) but how much of a risk is it and where do I have to monitor? In this session we’ll explore how effective cleanroom design and environmental monitoring programs are foundational to the contamination control strategy
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Lunch Break
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PIC/s Annex 1 Workshop/training on CCS-First Air- Barrier and Indirect Product Contact Parts
Since the publication of the PIC/s Annex 1 in 2022 my world journey started to discuss globally the implementation of the EU/GMP Annex 1 and the PIC/s Annex 1. During the almost three year I met around 16000people on Workshops, Conferences globally and did also global Inspector Trainings to more than 1500 Inspectors. During the workshop I`ll highlight the outcome of the Discussions and trainings I did on the Contamination Control Strategy CCS and what should be considered, the topic of First Air as many times discussed, Barrier technologies and what it require as well as the ongoing discussion about Indirect Product Contact Parts as stopper transfers and how to install them in Grade A.
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Coffee Break
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PIC/s Annex 1 Workshop/Training Part 2
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ICT Standard Time (UTC +7:00)
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Registration
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Session 3
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Interpreting Regulatory Guidelines for Contamination Control Strategy in Pharmaceutical Manufacturing
Contamination Control Strategy (CCS) is a critical framework that demonstrates how contamination risks are identified, controlled, and mitigated across the pharmaceutical manufacturing lifecycle. It applies to both sterile and non-sterile operations and serves as a cornerstone of ensuring product quality and patient safety.
An effective CCS integrates key elements such as facility and equipment design, personnel and material flow, cleanroom classification, air and water systems, validated cleaning and disinfection procedures, environmental and process monitoring, and container closure integrity.
This presentation will highlight the importance of a CCS, outline its essential components, examine relevant regulatory expectations from the EU EMA, US FDA, and ICH, and provide a practical roadmap for developing a robust and compliant contamination control strategy.
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GMP Inspections: Preparing for Success and Effective Response Strategies
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Coffee Break
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Session 4
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Driving Efficiency, Flexibility, and Compliance: How MES and EBR Enable Seamless Inspection
This presentation explores how Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR) serve as critical enablers for driving operational efficiency, manufacturing flexibility, and regulatory compliance in pharmaceutical production. By digitizing workflows and integrating real-time data capture, MES and EBR support seamless inspections, reduce human error, and ensure data integrity. We'll highlight practical use cases and benefits, showing how these technologies streamline batch review, enhance traceability, and prepare manufacturers for audit readiness in an increasingly complex regulatory landscape.
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Lunch Break
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Mastering Contamination Control Strategy (CCS) for Annex 1 Compliance Part 1
This workshop explores practical strategies for Annex 1 implementation with a focus on proactive approaches to contamination control strategy. Key topic includes role of Endotoxin in biofilm detection, early microbial contamination and importance of accurate microbial identification in environmental monitoring to support a proactive and risk-based CCS framework.
Attendees will gain insights on tying in modern and rapid technologies to support real time monitoring and trending, aligning to Annex 1’s emphasis on contamination control strategy and continuous process understanding.
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Coffee Break
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Mastering Contamination Control Strategy (CCS) for Annex 1 Compliance Part 2
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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.
Novotel Bangkok on Siam Square
392/44 Siam Square Soi 6, Rama I Road PathumwanBangkok, Thailand 10330
+66-2-209-8888
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