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2020 PDA/FDA Joint Regulatory Conference

The Future is Now: Effective Quality Management and Robust Manufacturing

Sep 14 - Sep 16, 2020
8:45 AM
-
5:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Conference
  • Online

Overview

The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 29th year. This flagship conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and related compliance issues in an ever-evolving landscape. This year’s theme is “The Future Is Now: Effective Quality Management and Robust Manufacturing,” and will explore the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms. The conference proceedings will delve into the details through the discussion of latest innovative technologies, case studies, regulatory expectations, and forward-looking perspectives in sessions, such as:

  • Commercialization challenges in cell and gene therapy
  • Data analytics in manufacturing
  • De-risking your Supply Chain
  • The Quality Assurance role in 2020 and beyond
  • ICH quality initiatives
  • OOS investigations
  • Process validation lifecycle
  • Combination products, diagnostics, and software as a medical device
  • U.S. FDA Emerging Technology Program
  • Using risk management to reduce the risk of drug shortage
  • Utilizing modeling in manufacturing

This year’s conference focuses on advancing quality management and the robust manufacturing of innovative drugs, biologics, and combination products. Combined efforts of industry and regulators are necessary to assure uninterrupted supplies of safe and high-quality products while advancing the use of new capabilities.

In addition to the above topics, attendees will also learn about hot topics such as supplier quality control, new large volume parenteral technical approaches, joint inspection program for sterile drugs, human performance tools to help strengthen deviation management, preventing nitrosamine impurities, and how regulators assess firms in times of crises. FDA senior officials will discuss Center-specific initiatives as well as provide compliance updates.

Learning Objectives

At the completion of this conference, participants will gain skills to:

  • Conduct successful investigations of Out-of-Specification (OOS)/Out-of-Trend (OOT) findings
  • Effectively implement data integrity remediation
  • Establish robust processes and maintain state of controls
  • Improve product availability and avoid shortages
  • Manage post-approval changes and change management processes
  • Successfully implement quality management techniques and robust manufacturing
  • Update facilities to support dependable quality and supply

Who Should Attend

Departments

Corporate Offices, Research and Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Function

Quality Assurance | Manufacturing | Compliance/Inspection Management | Supply Chain | Auditing | Executive Management

Academia

Pharmaceutical sciences | Regulatory science

Global regulatory authorities

Registration Fees

Register Now
Registration Type Price
Member $1916
Non-member $2139
Young Professional Member $958
Student Member $224
Student Non-Member $248
Gov't/Health Auth./Academic Member $560
Gov't/Health Auth. Non-Member $560
Academic Non-Member $640

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