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PDA Metro Chapter 14th Annual Chapter Day - Aseptic Processing : Quality by Design Event

May 02 - May 02, 2019
Bridgewater, NJ

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Overview

Many elements in an aseptic process assure product sterility. Consideration must be given to facility and primary engineering controls, employee training, equipment disinfection. Process simulations, environmental monitoring, and product testing, while important, are limited in their ability to assure product sterility. We have put together a full day of experts who will share their knowledge and experience of managing these critical control points.

Agenda

    • 7:00 a.m. - 8:15 a.m. Continental Breakfast, Registration, & Vendor Show  
    • 8:15 a.m. - 8:30 a.m. Welcome & Announcements
    • 8:30 a.m. - 9:10 a.m. Sterility by Design
      Presented by James Agalloco, Agalloco and Associates
    • 9:15 a.m. - 9:45 a.m. Engineering Considerations in Cleanroom Design and Construction
      Presented by Jim Wagner, CEC
    • 9:50 a.m. - 10:30 a.m. Critical Points for Effective Training of Aseptic Technique
      Presented by Eric Kastango, CEO, CriticalPoint Training
    • 10:35 a.m. - 10:50 a.m. Morning Break
    • 10:55 a.m.- 11:35 a.m. Process Simulations: Identify and Achieve Regulatory Compliance Requirements
      Presented by Karen McCulloch, MMI Associates
    • 11:40 a.m. - 12:20 p.m. Recent FDA Inspection Domestic and Global Trends, Findings & Warning Letters
      Presented by FDA Speaker: Russell Gampion (2nd speaker to be announced)
    • 12:20 p.m. - 1:20 p.m. Lunch
    • 1:30 p.m. - 2:10 p.m. Disinfection and Sterilization of Aseptic Processing Operations
      Presented by Madison Hoal, EcoLab
    • 2:15 p.m. - 2:55 p.m. Environmental Monitoring: Failures and Responses
      Presented by Frank Settineri, Veracorp
    • 3:00 p.m. - 3:20 p.m. Afternoon Break
    • 3:25 p.m. - 4:00 p.m. Panel Discussion/Q&A

Highlighted Speakers

James Agalloco
James Agalloco
Agalloco & Associates Inc.
Madison  Hoal
Madison Hoal
EcoLab
Eric Kastango
Eric Kastango
Clinical IQ, LLC and CriticalPoint, LLC
Karen Z. McCullough
Karen Z. McCullough
MMI Associates
Frank  Settineri
Frank Settineri
Veracorp, LLC
Jim Wagner
Jim Wagner
Controlled Environment Consulting, LLC

Travel

Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Bridgewater Manor

1251 US-206
Bridgewater, NJ

Directions

Registration Fees

Regular Price
Registration Type Price by April 25
PDA Member $299
PDA Non-Member $399

Late Registration/ Walk- Ins Price by April 26
PDA Member and PDA Non-Member $450




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