Registration
Welcome and Workshop Introduction
Keynote
Mr. Bayu Wibisono, S.Si, Apt., M.A.B. (invited)
  • MW

    Mr. Bayu Wibisono, S.Si, Apt., M.A.B. (invited)

    Director of Directorate of Drug, Narcotic, Psychotropic, and Precursor Production Supervision
Coffee Break
Essential for Contamination Control Strategy (CCS): Environmental Monitoring and Risk Assessment.
Hue Kwon

Updated EU GMP Annex 1 requires to use risk assessment in developing and/or adapting contamination control strategies.  Appropriate Environment Monitoring (EM) program is essential for ensuring sterility assurance as well as managing contamination risk. ICH Q9, Quality Risk Management must be incorporated in EM program to meet the FD, EMA, PIC/S standards and expectations.

  • Hue Kwon (Member, RAQAB at Parenteral Drug Association)

    Hue Kwon

    Member, RAQAB at Parenteral Drug Association
Application of Quality Risk Management in Contamination Control Strategy
Richard Chai

Minimizing the contamination risk is of utmost importance to prevent product contamination which can adversely affect patient safety. This presentation will provide a valuable insight into the use of quality risk management principles to identify and manage the contamination risk related to aseptic manufacturing process, from Annex 1’s perspective, as part of the overall Contamination Control Strategy.

The following topics are discussed in detail for this presentation:
· Regulatory requirements on Contamination Control in aseptic manufacturing.
· Quality Risk Management principles.
· Identification and management of contamination risks in aseptic manufacturing, including examples.

At the end of the presentation, the participants will have a better understanding on the Annex 1 requirement on contamination control, and also how to minimize the contamination risk through the use of quality risk management principles on the identification, evaluation and control of potential risks to product quality in any GMP manufacturing facilities to meet the Annex 1 requirements.

  • Richard Chai (Senior Technical Service Manager at STERIS Corporation)

    Richard Chai

    Senior Technical Service Manager at STERIS Corporation
QnA
Hue KwonRichard ChaiMr. Bayu Wibisono, S.Si, Apt., M.A.B. (invited)
  • Hue Kwon (Member, RAQAB at Parenteral Drug Association)

    Hue Kwon

    Member, RAQAB at Parenteral Drug Association
  • Richard Chai (Senior Technical Service Manager at STERIS Corporation)

    Richard Chai

    Senior Technical Service Manager at STERIS Corporation
  • MW

    Mr. Bayu Wibisono, S.Si, Apt., M.A.B. (invited)

    Director of Directorate of Drug, Narcotic, Psychotropic, and Precursor Production Supervision
Lunch
Regulatory Inspection Coverage on CCS
Peter Qiu

This presentation will share some general considerations on implementing Contamination Control Strategy and FDA's regulatory assessment of facility's CCS during CMC review and on-site inspections. The presentation will then provide detailed discussions on each of the six systems covered during an inspection with the focus on assessing the facility's implementation of CCS.

  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
How to Minimize Risk of Microbial, Endotoxin and Particulates Contamination
Richard Chai

Minimizing the contamination risk is of utmost importance to prevent product contamination which can adversely affect patient safety. This presentation will provide a valuable insight into the use of quality risk management principles to identify and manage the contamination risk related to aseptic manufacturing process, from Annex 1’s perspective, as part of the overall Contamination Control Strategy.

The following topics are discussed in detail for this presentation:
· Annex 1 requirement on Contamination Control in aseptic manufacturing.
· Identification and management of contamination risks by microorganisms, endotoxin and particulates in aseptic manufacturing, including examples.

At the end of the presentation, the participants will have a better understanding on the Annex 1 requirement on contamination control, and also how to minimize risk of microbial, endotoxin and particulates contamination through the use of quality risk management principles on the identification, evaluation and control of potential risks to product quality to meet the Annex 1 requirements.

  • Richard Chai (Senior Technical Service Manager at STERIS Corporation)

    Richard Chai

    Senior Technical Service Manager at STERIS Corporation
Industry Case Study
QNA
Richard ChaiPeter Qiu
  • Richard Chai (Senior Technical Service Manager at STERIS Corporation)

    Richard Chai

    Senior Technical Service Manager at STERIS Corporation
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech

The information presented at this conference is accurate as of its launch date. However, the organizers retain the right to modify, update, or amend any details as needed. As we aim to provide the most current information and updates, we encourage you to check regularly for any changes.