Eagle presents the most important seminar that sterile and non-sterile compounders must attend to understand regulatory compliance and patient safety. This event will prepare you to implement systems that will help your facility become compliant with the new regulations which will become official in December. This is event is open to all for registration. Space is limited.
Registration Fee: $495
- Educational Materials
- Breakfast, Lunch, & Snacks
- Transportation to & from EAGLE and PCCA International Seminar Opening Reception.
Inside the Mind of the FDA
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 noncompliance.
Dr. David Hussong
Former FDA Associate Director for New Drug Microbiology
Current Chairman of the USP Microbiology Expert Committee
Dr. Ross Caputo
Expert Microbiologist and sought-after consultant with over 30 years in the FDA regulated pharmaceutical industry.
KARLA PALMER
Eagle is pleased to announce that Karla Palmer, one of the nation’s top litigation experts on FDA 483 & Risk Mitigation issues, will be joining Dr. Ross Caputo and Dr. David Hussong as one of the speakers at the Quality Systems Seminar on Wednesday, October 9th in Houston, TX.
As a litigator with 25 years’ experience, Karla advises clients throughout the pharmaceutical supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of legal and regulatory issues. These matters include DEA and FDA regulations and guidance, government inspections (including Form 483s) and investigations, warning letters, consent decrees, and administrative and federal proceedings
Lessons from Recent Citations
Understand how to prepare for regulatory inspections through practical examples from recent and common citations.
Insanitary Conditions
Are you making these common mistakes which have led to regulatory consequences?
Quality Systems Development
Are personnel engaging in best practices? Do your systems qualify to ensure patient safety?
Topics Will Include
Practical Lectures That Will Help Safeguard Your Business
Quality Systems Development
Preparation for Regulatory Inspections
Investigations: When is it process, not product?
Qualifications, Validations & Calibrations
terminal sterilization processes; equipment and facility
qualifications; calibration and certification)
Seminar Schedule
7:00 a.m.
Registration & Breakfast
8:00 a.m.
Opening Announcements
Ross A. Caputo, PhD
8:15 a.m.
Quality Systems Development
8:45 a.m.
Preparation for Regulatory Inspections
Topics include: 503A exemptions,
insanitary conditions, and regulatory
consequences
9:45 a.m.
BREAK
10:00 a.m.
Qualifications, Validations and Calibrations
Topics include: Process validations, equipment and facility qualifications, calibration and certification
11:00 a.m.
Adjourn / Board Bus
11:15 a.m.
Buses Depart to EAGLE Facility
Noon
LUNCH
12:45 p.m.
Investigations: When Is It Process, Not Product?
Topics include: Root-cause investigations, corrective and preventive actions, and data trending and analysis
1:45 pm: BREAK
2:00 pm: Tour of Eagle
2:30 pm: Lab Practical
3:30 p.m.
Adjourn / Board Bus
4:00 p.m.
Buses Depart to Hilton Americas
5:00 p.m.
PCCA International Seminar Opening Reception
Travel & Accommodation
Hilton Americas-Houston
1600 Lamar St. • Houston, Texas 77010 • 713.739.8000
EAGLE Rate: $229.00 USD/night (discount rate ends 09/25/2019)
Enterprise Rent-A-Car’s Flex Rate Program gives EAGLE guests 5% off the current
rates at Enterprise Rent-A-Car locations nationwide when the reservation is made
through www.enterprise.com (Account Number: 06C3214).
Ground Transportation for Airport Transfers
(Attendee Is Responsible for Roundtrip Transportation to/from the Airport):
Merlo’s Charters – 866.367.5466 or merloscharters.com; A-Ambassador – 713.572.5466
or aambassador.com; Sugar Land Shuttle – 832.434.8312 or sugarlandshuttle.com.
Please make your reservations at least 72 hours in advance.
Registration Fee: $495
- Educational Materials
- Breakfast, Lunch, & Snacks
- Transportation to & from EAGLE and PCCA International Seminar Opening Reception.
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