Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Mountain States Chapter Phase Appropriate Training Event and Facility Tour

Sep 20 - Sep 20, 2018 |
Sep 20, 2018 |
BioMARC | Fort Collins, CO
  • Chapter
Add event to: ICal Outlook Google Calendar

Please join us on Thursday, September 20th in Fort Collins, CO for a tour of BioMARC and presentations by Samantha Gilchrist, and Timothy Reinhardt.  View the event online.

Tour of BioMARC and Presentation on Capabilities

BioMARC is a non-profit biologics Contract Development & Manufacturing Organization owned and operated by Colorado State University (CSU) serving bio-pharmaceutical companies and government agencies.

BioMARC specializes in high containment: Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3), CDC Tier 1 select agents, and spore-forming microorganisms. Development and manufacturing are performed under phase appropriate cGMP conditions for pre-clinical, clinical and commercial products. Services include process and method development, cell and virus banking, bulk drug manufacturing, stability, and aseptic/viral fill finish.  Projects involve vaccines, bio-therapeutics, and diagnostic reagents in our FDA and CDC inspected state-of-the-art facility.

Phase Appropriate Training by Timothy Reinhardt

This session provides the basic training principles and practices of a robust Quality System for early phase manufacturing in the pharmaceutical industry. The presented material applies to the biopharmaceutical, diagnostic and device industries and to suppliers, including API manufacturers. Discussions will include the role of training, major elements of pharmaceutical quality training, the impact of management practices and the features of an effective training organization. This course discusses current training requirements, exploring guidance from both the FDA and the MHRA. The course is presented in an open, interactive manner, encouraging discussion throughout.

Agenda

  • 4:30pm Registration and Networking
  • 5:00 pm Tour of BioMARC
  • 5:30 pm BioMARC Overview
  • 6:00 pm Phase Appropriate Training
  • 7:00 pm Close

Registration

Registration is free.

Location

Detailed directions will be provided to the registrants via email.
Please note: There is gated access to this campus.

All guests should arrive by 05:30 PM. Attendees may leave at any time.

Biographies

Samantha Gilchrist, Quality Assurance Specialist BioMARC, B.S. Biology
With over 9 years of Quality experience working with quality assurance specialists, engineers, and microbiologists Samantha has over 6 years of Quality Management System, (QA) and Document Control (DC) experience in the pharmaceutical industry. She demonstrates excellence in quality by example, to meet regulatory and internal standards. She maintains the Quality Assurance for a contract manufacturing for pre-clinical to commercial drugs and biologics. She leads the Document Control program and maintains all project and non-project specific documentation for the site. Samantha also maintains and coordinates the Environmental Health and Biosafety program for BioMARC along with CSU officials. Maintains site compliance to ICH Q7, 21 CFR part 210 and 211, and applicable regulatory standards. Responsible for key Quality systems: batch release, deviation, CAPA, internal audits, change control and laboratory OOS investigations. She has a Bachelor of Science in Biology, from Colorado State University.

Jordan Flatt, Production Associate at BioMARC, M.S. Microbiology
Jordan has over five years of manufacturing and process development experience in the pharmaceutical industry. He works under BSL-2, BSL-3, and Tier 1 Select Agent conditions within BioMARC to produce vaccines, therapeutics, and diagnostics for a variety of infectious diseases. He is responsible for helping take these drug products from pre-clinical development through clinical and commercial production. He works on every stage of the production process, from the initial upstream cell culture to downstream purification and fill/finish. He is also responsible for the creation, review, and revision of controlled documents within BioMARC, such as Batch Records, SOPs, and Reports. He has a Master of Science in Microbiology, from Colorado State University.

Kaitlyn Szlosek, Quality Control Analyst, BioMARC, B.S. Biomedical Sciences, M.S. Toxicology
Kaitlyn has over 4 years of Quality Control experience with analytical method development, transfer, verification, and qualification in the biopharmaceutical industry. She has over 3 years of experience working in high-containment BSL-3 laboratories. She is unparalleled as the lab lead within the department, ensuring compliance with GMP, GLP, ISO, USP, CFR, and/or ICH, where applicable. Her experience spans several products and over 15 technologies. She fronted the reconstruction of the environmental monitoring system and continues to coordinate and maintain compliance with applicable regulatory standards. She has a Bachelor of Science in Biomedical Sciences and a Masters in Toxicology, from Colorado State University.

Timothy Reinhardt, Sr. Consultant/Site Manager, RMC Pharmaceutical Solutions
Timothy Reinhardt has worked in the pharmaceutical industry since 1992 and prior to joining RMC had 18 years of quality leadership at Pfizer. Along with his role as Director of Manufacturing and Supplier Quality Assessment at Pfizer, Tim was also the former leader of the Site Quality Auditor Training certification program, responsible for creating and presenting quality training to various staff across the globe.

Exhibits and Sponsors

We welcome companies interested in supporting the event and promoting products and services to attendees of the event.

Contact Mountain States Chapter President Suzanne Mecalo to inquire about sponsorship and exhibit opportunities.

Closed
https://store.pda.org/Meetings/Login.aspx?ID=4581

Directions