14:00 – 14:10
Welcome & Introduction
Richard Johnson, President, PDA
Marcel Ewals, Executive Director, PDA Asia Pacific
Bruce Loxley, Steering Committee Chair and President, PDA Singapore Chapter


The regulatory part of the conference will give an update on the upcoming GMP Annex 1 document. An inspector will share the latest version of the document, highlight the new parts and share what the future expectations will be. Industry representatives will summarize the position of the pharmaceutical industry, and the trends in international inspections will be shared. Risk management and data handling play a significant role in the new regulations, and therefore two presentations will share the essentials.

This session continues with discussions and questions. In addition, the perspective of PDA and from the pharmaceutical industry will be given.

Moderator: Bruce Loxley, President, PDA Singapore Chapter

14:40 – 15:25
Industry Perspective on Annex 1 Draft
Gabriele Gori, GSK, Co-Chair of the PDA comment team on Annex 1
Di Morris, GSK, Co-chair of the PHSS comment team on Annex 1

15:25 – 15:55
GMP inspection trends – Industry perspective
Yvonne Kwan, Executive Director, Amgen Singapore Manufacturing

15:55 – 16:25
Panel Discussion and Q&A
Moderator: Bruce Loxley

• 

  Gabriele Gori

  Vice President, Head of Audit & Risk Management at GSK Vaccines
• 

  Yvonne Kwan

  Executive Director of Amgen Singapore Manufacturing
• 

  Di Morris

  Audit Manager at GSK
• 

  Rico Schulze

  GMP Inspector at Office of the Stateminister of Saxony, Germany

The upcoming regulations asks for detailed manufacturing understanding with a risk management of the process, including equipment/machines, IPCs/sensors and personnel activities. Two presentations will address risk-based approaches for maintenance of manufacturing equipment to ensure reliable product quality but also production efficiency and cost advantages. The new requirements for aseptic process simulation, interventions, personnel involvement and general risk mitigation strategies will be discussed. Finally the topic of aged facilities will be addressed and potential ways to upgrade such facilities to reach a standard which complies with the new regulations. PDA´s technical reports on these topics will describe the current best practices. There will be panel discussions to answer any questions.

This session will focus on the implementation of risk-based approaches in manufacturing.

Moderator: Bruce Loxley, President, PDA Singapore Chapter

16:00 – 16:30
New Requirements for Personnel, Aseptic Processing and Aseptic Process Simulation in Latest Draft Annex 1
Goh Choon Wee, Senior Compliance Audit Manager, Roche

16:30 – 17:00
Sampling in an Aseptic Process – Risk Mitigation & Regulatory Compliance
Somasundaram G., Senior Technical Consultant, APAC, Process Solutions, Merck KGaA

17:00 – 17:30
PDA Standard Practice for QRM of Aseptic Processing
Hal Baseman, COO, Valsource

17:30 – 18:00: Upgrading Aged Facilities and Manufacturing Lines
Review of Aging Facilities: The Impact and Further Options
Maik Jornitz, President, G-CON, Chair of the PDA Taskforce

18:00 – 18:30
Panel Discussion and Q&A
Moderator: Bruce Loxley and Georg Roessling

• 

  Hal Baseman

  Chief Operating Officer at Valsource Inc
• 

  Somasundaram G.

  Senior Technical Consultant, APAC at Merck KGaA
• 

  Choon Wee Goh

  Senior Compliance Audit Manager at Roche
• 

  Maik Jornitz

  President & CEO of G-CON Manufacturing

For any pharmaceutical manufacturing facility, a robust contamination control strategy is important. Injectable products, especially microbiological aspects, are most relevant for this.

This session will start with an update of the latest micro chapters of USP. A US FDA regulator will present observations from international GMP inspections and will share thoughts about future improvements. Following on, the it will focus on Environmental Monitoring, control, EM trending and how to apply risk-based approaches in cleaning and disinfection.

The conference will close with a session on new microbiological technologies especially rapid micro methods. A case study will highlight what technologies are available, and how they can be used best.

In the Annex 1 draft, it is requested that a contamination control strategy is implemented across the facility. Important elements of that are cleaning and disinfection, monitoring and trending and preventive actions. This session will present examples using risk-based approaches to achieve the regulatory requirements.

Moderator: Emily Cheah, Managing Director of Charles River Laboratories Singapore (Microbial Solutions)

10:45 – 11:25
Risk-based Environmental Monitoring Program
Ziva Abraham, CEO, Microrite

11:25 – 11:55
A Risk-based Approach to Cleaning & Disinfection
Jim Polarine, Senior Technical Service Manager, STERIS Corporation

11:55 – 12:25
Annex 1: Making Sense of EM Microbial Trending and Driving Effective CAPA Plans
Ulrich Herber, Director of Technology and Market Development, Charles River Laboratories

12:25 – 13:25
Panel Discussion and Q&A
Moderator: Emily Cheah and Georg Roessling

• 

  Ziva Abraham

  CEO of Microrite
• 

  Thomas Arista

  Field Investigator at US FDA
• 

  Ulrich Herber

  Director of Technology and Market Development at Charles River Laboratories
• 

  Jim Polarine

  Senior Technical Service Manager at Steris Corporation
• 

  Radhakrishna Tirumalai

  Principal Scientific Liaison-General Chapter, Science Division at USP
• 

  Andrew Hopkins

  Director of Compliance at Abbvie