Compliance Through Science

A Pre-Seminar Conference Sponsored By EAGLE
Wednesday, October 26, 2022 │ In-Person Attendance Only

After two years, EAGLE is back to bring together all the finest experts in quality and compliance to discuss a variety of elements that can offer exceptional educational benefits. Attendees of this conference will gain an understanding of cleanroom requirements, environmental monitoring, proposed changes to USP, insanitary conditions, stability studies, and transitioning from 503A to 503B. As a company that provides science-based solutions, EAGLE’s top priority is for our clients to be knowledgeable in all areas related to pharmacy.

Pricing

PCCA Members & Eagle Clients Attending International Seminar 2022 – FREE

PCCA Members & Eagle Clients NOT Attending International Seminar – $249.00 Per Person

In Person Only, No Virtual Offering

Pre-Seminar Event Registration includes IN-PERSON access to education, plus:

  • Breakfast
  • Lunch
  • Refreshment Break
  • Downloadable audio recording of the event

Registration is open to all PCCA members and Eagle clients.

If attending International Seminar 2022, there is NO CHARGE for this EAGLE conference; however, you must register for this event.

Agenda

CE credit will not be offered for this program.

Wednesday, October 26

7:00 am

Registration & Breakfast

8:15 am

Opening Announcements

8:30 am

Quality Compliance

Learn about proposed changes to USP 795 and USP 797 and how these changes can affect your facility if the revisions become effective. 

9:15 am

Quality Compounding Facilities

Understand how using qualification, certification, calibration and preventive maintenance can ensure that your facility and equipment support safe compounding operations.

10:00 am

Break

10:15 am

The Pillars of an Effective Environmental Monitoring Program and its Importance

A thorough environmental monitoring program is essential for pharmacies to understand the impact that daily operations have on controlled environments. During this session, you will be presented with sampling strategies and how to effectively react to adverse trends.

11:00 am

Break

11:15 am

Stability of Compounded Formulations: Science & Guidance

This discussion will focus on a risk-based approach for stability/BUD studies to comply with current FDA guidelines, and stability indicating methods and their use while testing formulations to establish their expiry/BUDs.

12:00 pm

Lunch

1:00 pm

From 503A to 503B: Path to Success

Get an overview of the compliance requirements to transition and operate a successful 503B outsourcing facility from a 503A compounding pharmacy.

1:45 pm

Break

2:00 pm

Filth and Insanitary Conditions – Impacts on Products and Regulatory Observations

Pharmaceutical compounding activities require a clean and controlled environment, especially when preparing sterile products. Regulatory agencies (i.e., FDA) have made this law and have published guidance explaining their general expectations. This presentation will discuss specific examples of deviations and regulatory actions related to insanitary conditions.

3:00 pm

Break

3:15 pm

Understanding Your Testing at EAGLE

Discover the latest information on EAGLE’s laboratory testing and consulting services, as well as our product offerings.

4:00 pm

Win a Prize! Kahoot Quiz

4:30 pm

Adjourn

PCCA Speakers and Eagle Speakers


Gus Bassani
PharmD

Gus Bassani, PharmD, currently serves as Chief Scientific Officer for PCCA, a Houston-based, FDA-registered supplier of active pharmaceutical ingredients, excipients and technical consulting to pharmacies, healthcare institutions and outsourcing facilities. In addition to the scientific and technical responsibilities of his position, Gus is regularly engaged in legislative, regulatory and public affairs activities. Gus worked in multiple pharmacy practice and industry settings, and taught extemporaneous compounding principles to pharmacy students in Drake University's Pharmaceutics Laboratory course. He received his Doctor of Pharmacy degree from Drake University College of Pharmacy and Health Sciences.

Robert Byrne
PhD

Robert Byrne, PhD, earned his PhD in Chemistry at the University of Notre Dame in 1980. He continued his academic studies as a Post-Doctoral Research Fellow in Biochemistry and as a Research Associate/Assistant Professor at University of Chicago. Robert has built an extensive industrial background in R&D and Operations. He has also managed GMP/GLP laboratory operations and has also contributed quality and regulatory consulting services in the medical device, drug, and vaccine industries. As Eagle’s Vice President of Scientific Affairs, Robert’s diverse experience is a key influence in the implementation of methodologies that improve Eagle’s laboratory operations.

Ross A. Caputo
PhD, President of EAGLE

Ross A. Caputo, PhD, President of EAGLE, earned his PhD 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.

Andrew Eng

Huy (Andrew) Eng joined EAGLE in 2018 and worked on the Sample Management team. Today, Andrew is EAGLE’s Business Development Manager, serving as the liaison between the laboratory and EAGLE’s clients. In this role, he assists in resolving any issues that may arise. Andrew earned his bachelor’s degree in Psychology with academic minors in Business Administration and Music from Baylor University.

Jacqueline Esqueda
BS, PharmD

Jacqueline Esqueda, BS, PharmD, received a Bachelor of Science in Chemistry and later received a Doctor of Pharmacy from the Feik School of Pharmacy in San Antonio. Prior to joining the EAGLE Team, Jacqueline worked as an R&D Scientist for a contract drug manufacturing organization where she was responsible for analytical method development, formulation development, and process development from the laboratory through the manufacturing scale. As a pharmacist, Jacqueline was responsible for the startup and production operations of a 503B outsourcing facility including but not limited to the development and implementation of all SOPs, formulations, processes, and the training of all staff in both sterile and non-sterile drug production.

Miguel Hernandez
MS

Miguel Hernandez, MS, is a pharmacist who received his education at the Santa Maria University in Caracas, Venezuela. After graduating, Miguel continued his education and received a Master of Science in Industrial Engineering from the Universidad Nacional Experimental Politécnica (UNEXPO) in Caracas. Miguel has worked in the GMP pharmaceutical field since 2006. During this time, he worked at companies like Sanofi and Merck KGaA, performing various roles in operation such as quality control, validating manufacturing processes, cleaning validation analyses, and has served as a Production Supervisor of the Solid, Liquid and Semisolid Manufacturing department.

Robert Hernandez

Robert Hernandez started his career as a pharmacy technician at H-E-B in 2012. In 2018, H-E-B recognized Robert with The Lupe Saucedo Outstanding Technician Award for the Houston region. Due to the growing demand of vaccinations that occurred during the COVID-19 pandemic, Robert became an immunizer at his pharmacy to help meet that demand. While working as a pharmacy technician, Robert obtained his bachelor’s degree in Mechanical Engineering from the University of Texas at Tyler. In 2021, Robert joined EAGLE as an Engineer and recently earned a promotion, in part, to his outstanding knowledge and performance of calibrations and certifications within the metrology lab.

David Hussong
PhD

David Hussong, PhD, joined the EAGLE team in January 2018, and has over 40 years of experience, including 30 years with the FDA as a regulatory scientist. Most recently, he was a consultant to the pharmaceutical industry. His research has been focused on studies of microbial recovery and detection methods. In Dave’s position as EAGLE Chief Technical Officer, he assists in scientific and regulatory matters for analytical testing of products and pharmacy support services.

Jay Patel
PhD

Jay Patel, PhD, joined the EAGLE team in 2021 and has extensive experience in analytical chemistry and synthetic organic chemistry. Previously, he was the Manager of Research & Development and Quality Control at WDPrx, where he has successfully managed multiple NDA/ANDA projects from their inception to commercial launch by navigating them through the rough waters of regulatory agencies. In Jay’s current role as the Director of Analytical Sciences, he leads a team of R&D and QC chemists to deliver efficient analytical testing for 503A and 503B compounding pharmacies formulations (sterile and nonsterile formulations) as well as NDA & ANDA products for pharmaceutical companies.

Ashley Trueheart
MS

Ashley Trueheart, MS, joined the EAGLE team in 2015. She earned her Master’s degree in Biological Science specializing in Molecular Biology from the University of Houston. Prior to joining EAGLE, Ashley worked in food microbiology gaining experience in PCR assay testing of detection of major pathogens and environmental samples. Before becoming EAGLE’s Director of Product Design and Development, she was EAGLE’s Microbiology Manager.

Billing and Cancellation Policy

All registrations will be billed immediately to your preferred credit card. Billing to member accounts is no longer available. Full refunds available through Friday, Oct. 7, 2022. The registration fee will not be refunded for any cancellations received after Friday, Oct. 7, including no-shows. Hotel reservation cancellations must be handled directly with the hotel and are subject to the hotel’s cancellation policy.