2023 PDA Annex 1 Workshop Series (Singapore)

The final version of Annex 1 was published on 25 August 2022 and will come into force on 25 August 2023. Exempted from this is Chapter 8.123, deadline for which is on 25 August 2024. PDA Asia Pacific is holding a two-day workshop on the important changes practitioners, consultants and suppliers alike must understand and prepare for.

By attending this workshop:

• delegates will acquire insights from regulators involved in the Annex 1 development and review process.
• delegates will be able to identify the key design and operational aspects of aseptic manufacturing facilities impacted by the revised Annex 1.
• delegates will be able to develop and implement a contamination control strategy to ensure performance and quality.
• delegates can discuss and seek advice on the implementation challenges in a safe space with Industry colleagues.

Target Audience, personnel involved in:

• regulatory affairs and compliance
• aseptic or low bioburden manufacturing operations
• quality control (focus on Microbiology)
• training
• facility design, engineering and technical services