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PDA Virtual Conference

2020 PDA Asia Pacific Pharmaceutical Manufacturing and Quality

Emerging Regulatory Trends and Their Impact – Virtual Conference

Sep 22 - Sep 24, 2020
Singapore Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Asia-Pacific

Overview

The conference will give an update on the emerging GMP and compliance regulations and its impact on pharmaceutical manufacturing and quality functions. This will include an overview of the upcoming changes and your required dealings in a pharmaceutical environment. An important part of the conference is dedicated to the implementation of risk-based approaches in manufacturing.

Presentations will include topics on:

  • Control Strategy, as part of the quality system
  • Manual Aseptic Processing to Modern Fill Finish Operations
  • Aseptic Process Simulation
  • Data Integrity and Challenges for Quality Control Labs
  • Microbiology for Sterile and Non-Sterile Manufacturing, including modern techniques like rapid micro methods
  • New Technologies

Agenda

  • Day 1
  • Day 2
  • Day 3
  • REGULATORY

    • 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.

    For a detailed breakdown of the sessions and speakers, kindly access the agenda here.

  • MANUFACTURING

    • 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.

    For a detailed breakdown of the sessions and speakers, kindly access the agenda here.

  • MICROBIOLOGY

    • 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.
    • 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.

    For a detailed breakdown of the sessions and speakers, kindly access the agenda here.

Registration Fees

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Registration Type Price
3-Day Virtual Conference Pass $499
3-Day Virtual Conference Pass (Early Bird - Before August 22) $399
1-Day Virtual Conference Pass $199
1-Day Virtual Conference Pass (Early Bird - Before August 22) $159
3-Day Virtual Conference Pass (Group of 10) $3,590

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