Pre-International Seminar Session
Join Us The Day Before International Seminar

Quality Systems: The Management of Insanitary Conditions – A Pre-Seminar Conference Sponsored by EAGLE

Learn more about the science behind patient safety at this pre-seminar session, presented by EAGLE. Industry experts Ross A. Caputo, PhD, and David Hussong, PhD, will lead interactive lectures with sessions to help you understand the basic requirements of quality systems, the roles of the designated person as outlined in the new USP chapters, how to prevent insanitary conditions and the regulatory consequences of non-compliance. PLUS, you’ll have the exclusive opportunity to tour EAGLE’s brand-new facilities in Houston and observe EAGLE testing procedures firsthand.

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Ross Caputo
PhD, Eagle President

Ross A. Caputo, PhD, president of EAGLE, earned his doctorate in microbiological physiology and Immunology from Miami University in 1976, and has over 30 years of experience in the FDA-regulated pharmaceutical industry on sterilization research and aseptic processing focusing on process optimization and control. He has authored more than 50 publications and owns 15 patents, all related to infection control, sterilization processes and the production of sterile product. Ross started his career as a senior scientist in microbiology at the American Sterilizer Company (AMSCO), currently knowns as Steris. While at AMSCO, he was involved in the development of sterilizers for all healthcare use, including hospital, dental and industrial applications. Throughout his career, Ross has been an active participant and committee member of organizations such as AAMI/ISO and PDA, which are charged with the development of standards for the regulated marketplace.

Thursday, Oct. 10, 4:30 pm: Quality in Compounding: A Wake-Up Call for Our Industry

Friday, Oct. 11, 10:30 am: WORKSHOP QUALITY TRACK: USP <797>: How Changes Impact Your Pharmacy

Friday, Oct. 11, 2:30 pm: Patient Safety and How to Respond to Investigations

David Hussong
PhD, Eagle Chief Technical Officer

David Hussong, PhD, earned his doctorate in microbiology from the University of Maryland. David has 46 years of professional microbiology experience, including 30 years with the Food and Drug Administration (FDA), during which time he led the microbiology inputs to the 2004 Guidance on aseptic processing, and was a lead editor for the 1994 Guidance for sterile product application information. David is currently the chair of the USP Microbiology Expert Committee for the 2015-2020 cycle. He has been a member of the Parenteral Drug Association since 1993 and the American Society for Microbiology since 1975.

Friday, Oct. 11, 10:30 am: WORKSHOP QUALITY TRACK: USP <797>: How Changes Impact Your Pharmacy

7:00 am

Registration and Breakfast

8:00 am

Opening Announcements – Ross A. Caputo, PhD

8:15 am

Quality Systems Development

8:45 am

Preparation for Regulatory Inspections

Topics include: 503A exemptions, insanitary conditions and regulatory consequences

9:45 am

Break

10:00 am

Qualifications, Validations and Calibrations

Topics include: Process validations, equipment and facility qualifications, calibration and certification.

11:00 am

Board Bus

11:15 am

Bus Departs for EAGLE

12:00 pm

Lunch

12:45 pm

Rotating Afternoon Sessions

  • Group 1: Investigations: When Is It Process, Not Product? Topics include: Root-cause investigations, corrective and preventive actions, and data trending and analysis.
  • Group 2: Lab Practical
  • Group 3: Tour of EAGLE
3:45 pm

Adjourn and Board Bus

4:00 pm

Buses Depart for Hilton Americas

5:00 pm

PCCA International Seminar Opening Reception

No ACPE credits will be offered for this program.

Venue

Hilton Americas-Houston
1600 Lamar St
Houston, Texas 77010
713.739.8000

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Pricing

PCCA Members and EAGLE Customers – $495.00 each

Registration fee includes all educational programming, plus:

  • Full breakfast buffet
  • Lunch
  • Refreshment breaks
  • Transportation to and from EAGLE
  • PCCA International Seminar opening reception

Registration is open to all PCCA members and EAGLE customers.

Our Money-Back Guarantee

PCCA takes great pride in developing the highest quality educational programs and providing top-notch networking and sharing opportunities at our events. Our policy is to provide you with a full refund of the purchase price of the program if it hasn’t met your educational goals.

If you are not satisfied with our educational content for this EAGLE program, your refund must be requested by Wednesday, Oct. 23, 2019. To request a refund, email education@pccarx.com and include the attendee name, email address, phone number, 2019 EAGLE Pre-Seminar Session and a detailed explanation of why a refund is being requested. All refunds will be issued via the original payment method.

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Billing and Cancellation Policy
Your registration will be billed immediately to your preferred credit card. Billing to member accounts is no longer available. Please ensure your registration is confirmed before purchasing airline tickets. If you do not receive your confirmation letter within one week, please call to confirm receipt of your registration.

Full refunds are available through Wednesday, Oct. 2, 2019. The registration fee will not be refunded for any cancellations received after Wednesday, Oct. 2, including no-shows. Hotel reservation cancellations must be handled directly with the hotel and are subject to the hotel’s cancellation policy.