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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Southern California Chapter Aging Facilities Event

Nov 16 - Nov 16, 2017 |
Nov 16, 2017 |
Allergan, Inc. (Speaker Location) | Irvine, CA
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Thursday, 16 November 2017

Registration, Networking and Light Snacks, : 4:00-5:30PM
Opening Remarks, Presentations/Q&A and Closing: 5:30-7:30PM

Presentations

Remediation Challenges of Aging Facilities, Ronald Berk, Vice President, Hyde Engineering + Consulting, Inc.
Aging is an unavoidable part of a facility's life cycle. It is imperative that the facility owner constantly evaluate the impact of aging to the prime purpose of a GMP facility: consistent output of quality products. Aging of pharmaceutical manufacturing facilities has challenges in assessment and mitigation. This presentation will review some of the most common artifacts of aging, how to monitor the risk to supply chain interruption and, through some case studies, the challenges involved with mitigation or replacement of aging equipment or facilities.

Aging Facilities: PDA's Points to Consider Document, Sue Schniepp, Fellow, Regulatory Compliance Associates Inc.
This presentation will discuss the background and challenges of aging facilities and their impact on pharmaceutical manufacturing, including drug shortages and product recalls as well as the rationale and purpose behind PDA's Points to Consider Document on Aging Facilities. The document reflects the general thoughts and suggestions of industry experts on how to identify and modernize aging facilities thus ensuring a continuous supply of quality products to patients.

Registration

Register online, on or before 14 November 2017

Attendee Early Registration Fees (Submitted on or before 9 November 2017)

$50 PDA Member
$65 Non-PDA Member
$25 Government Employee or Student (this discount is not available online for nonmember students and government employees.  Please contact membership@pda.org for registration discount if you are not a current member)

There is no charge for Allergan employees at the Allergan location, or for KGI PDA Student Chapter Members at KGI who register by November 9, 2017. (All Allergan and KGI Student Chapter PDA Members must register. Please note: there is a $10 charge after November 9th, see below.)

Late Registration Fee (After 9 November 2017)

$10 Additional Charge to all registration fees listed above (including Allergan employees and Keck PDA Student Chapter members who register after November 9, 2017).

Cancellations: Receive a full refund on cancellations received on or before November 2nd.  Receive 50% refund from November 3-9.  Money is nonrefundable if cancellations are received after Thursday, 9 November 2017. Substitutions: Please no substitutions allowed.

Trouble registering online? Download the manual registration form here.

Speakers

Ronald Berk joined Hyde Engineering + Consulting in 1999. As VP of Engineering, Ronald is responsible for all engineering projects executed by Hyde EC. Ronald has extensive experience in capital project management and bioprocess engineering of biotech facilities and equipment, including start-ups, commissioning, qualification and remediation of aging facilities. He has worked on design of fill finish facilities, biotherapeutic and vaccine manufacturing facilities. His design experience includes implementation of hybrid design utilizing an optimum mix of stainless steel reusable equipment and single use equipment. Ronald's career began in Nuclear Power, as a Process and Layout Engineer with Stork Engineers and Contractors. He was responsible for process engineering and plant layout design and piping plan design. In addition to his depth of experience in design and project management, Ronald has served as an expert witness and consulted on complex litigation cases for large construction projects.  

Susan Schniepp has over 38 years of experience in Quality Assurance serving in leadership roles at Searle Pharmaceuticals, Abbott Laboratories, Hospira and OsoBio Pharmaceuticals, LLC. Sue currently serves on the Board of Directors for the Parenteral Drug Association and served as the Chair of the PDA/FDA Joint Regulatory Conference as well as a conference presenter. Sue has also served as Chair of PDA’s Regulatory Affairs and Quality Advisory Board. She was awarded PDA’s Distinguished Service award in 2008, Service Appreciation Award in 2014 and 2017, the Frederick J Carleton Award in 2015 and the Gordon R Personeus Award in 2010.

Sue’s publications include the book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards Setting Process for which she was awarded PDA’s Distinguished Author Award in 2007. Sue co-edited and contributed to the book Pharmaceutical Outsourcing: Quality Management and Project Delivery published in 2013. Since 2007, Sue has served as a columnist and member of the editorial advisory board for Pharmaceutical Technology Magazine. She was also Chair of a USP Monograph Development Expert Committee from 2005-2010 and served on USP’s Executive Committee of the Council of Experts from 2005 – 2007. Sue can be reached at s.schniepp@rcainc.com.

Two Locations to Choose From

The event will be hosted in three Southern California locations with a simulcast between venues – the speakers will be at the Allergan facility in Irvine with a webcast feed to the Los Angeles (KGI) and La Jolla (Organogenesis) locations.

  • Orange County (Irvine), Allergan, Speaker Location: 2525 Dupont Drive, Irvine, CA 92612
  • Los Angeles County, (Claremont), Keck Graduate Institute, WEBEX, 535 Watson Drive, Claremont, CA 91711

The Speakers are Brought to You By

Hyde

Hyde Engineering & Consulting
Hyde is a global design and consulting organization providing process system design, commissioning and validation, FDA compliance, and state-of-the-art cleaning technologies to pharmaceutical, bioprocess and other regulated process industries

 


Regulatory Compliance Associates

Regulatory Compliance Associates Inc.
Regulatory Compliance Associates Inc. (RCA) provides worldwide services to the life science industries to assist with resolution of compliance and regulatory challenges.  We understand that scrap rate and efficiency issues at aging cGMP facilities will eventually force manufacturers to upgrade existing manufacturing lines.  Minimizing risk and downtime requires optimally navigating planning, validation and regulatory aspects.  We work strategically to decrease the regulatory filing category wherever possible and provide Subject Matter Experts that are a strategic blend of top industry veterans and experienced consultant to have you up and running in months instead of years.

Exhibit

Download the exhibitor registration form here and return to membership@pda.org

Your fee includes: 6'foot table, logo & company description on all marketing material w/ hyper link,1-2-minute announcement, two admission tickets,10% exhibitor discount to vendor night on February 28, 2018 at the Richard Nixon Library, Yorba Linda, CA

Cancellations: Receive a full refund on cancellations received on or before November 2nd.  Receive 50% refund from November 3-9.  Money is nonrefundable if cancellations are received after Thursday, 9 November 2017. Substitutions: Please no substitutions allowed.

Save the Date: 7th Annual Industry Summit and Exhibitor Showcase, February 28, 2018

Closed
https://www.pda.org/chapters/north-america/southern-california/event-detail/pda-southern-california-chapter-event-registration

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