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

Speakers

Bruce Loxley (Co-Chair)

Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK

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Lisa Bennett (Co-Chair)

Senior GMP Consultant and Trainor at SeerPharma

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Matthew Davis

Inspections Team Lead & Senior Inspector Manufacturing Quality Branch at Therapeutic Goods Administration

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Emily Cheah

Managing Director of Charles River Laboratories

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Francesco Cicirello

Director, Quality Assurance of Evelo Biosciences

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Matthew Cokeley

Global Technical Consultant Regional Leader at Ecolab

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Richard Denk

Senior Consultant Aseptic Processing & Containment at Skan AG

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Derek Duncan

Director of Product Line at LIGHTHOUSE

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See all speakers

Agenda

Registration
P1: Overview of and Revision Process for Annex 1
Welcome Remarks from Workshop Co-Chairs
Regulatory Perspective
Insights from a Former Regulator
Registration
Day 1 Report Out
P4: TR90 - Contamination Control Strategy Development
Introduction to CCS Development & a Case Study
Considerations of Annex 1 for Advanced Therapy Medicinal Products
See full agenda

Location

PARKROYAL on Beach Road
7500A Beach Road
199591
Singapore

See route

Contact us

For additional event or venue information, please email asia-pacific@pda.orgYou can also reach us at +65 64965504

Book a hotel room through us at ParkROYAL on Beach Road


A limited number of rooms were blocked for attendees of the PDA Annex 1 Workshop at the workshop venue - ParkROYAL on Beach Road. The room rates quoted below are on a per night basis and subject to 10% service charge and prevailing government taxes. The rooms include complimentary daily breakfast and unlimited internet access. Check-in time is 3:00 p.m. and check-out time is 12:00 p.m. 

 

  • Single Room at SGD 285++ / night
  • Twin or Double Room at SGD 315++/ night


Please note that the rooms and the rates will only be available until 15 April 2023. After this date, we cannot guarantee these rooms and rates and will be subject to the hotel's availability.

 

To book a room, please click here​.

 

How to get here

PARKROYAL on Beach Road is located about 17km away from Changi Airport.

Public Transport such as buses and MRT trains are easily accessible from the hotel, with the nearest MRT stations being Bugis and Nicoll Highway- both only about five minutes away.

 

Contact Us

Email: rekah@parkroyalhotels.com

Phone Number: +65 6505 5774

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