When: Wednesday, April 19, 2017 4:30 – 8:00 pm
Where: Hyland’s 13301 S. Main Street, Los Angeles, CA 90061
Host: Rich Walton, Vice President, Manufacturing, Facilities & Engineering, Hyland’s (Standard Homeopathic)
Synopsis of Presentation: The Principles of Implementing Good Manufacturing Practices (cGMP’s) and Validation of FDA Licensed Facilities The presentations will address the necessary cGMP principles associated with the design, construction and commissioning of a FDA licensed facility. Validation will address the implementation of the qualification program, necessary documentation and executions of all qualified systems and equipment.
GMP – current Good Manufacturing Practices (Justin Cantor)
- What are they
- Who do they apply to
- Why are they required
- Who regulates them
Design/Build for cGMP (Chris Humphrey)
- When do they start, how is it controlled
- Commissioning – Documentation (TOP’s)
Validation (Charles Heldebrant, PhD)
- What is it
- Why is it required – Purpose
- When does it start on a project
- Who does it
- Key elements of validation
- IQ, OQ, PQ protocols
- Final reports / stability lots
- BLA License
About the Facility Tour:
Hyland‘s has constructed a new cGMP manufacturing facility in the heart of Los Angeles. This tour is an opportunity to view the facility prior to start-up of full-scale operations. The facility is capable of concurrent production of different products, including high volume operations for manufacturing bulk tablets, bulk liquids, intermediate powders, intermediate liquids and packaging bulk tablets and bulk liquids. The facility includes controlled manufacturing, manufacturing support, warehouse, offices, lab, mechanical, and support areas.
Justin Cantor, Director, PSC Biotech
Charles Heldebrant, PhD, Chief Scientific Officer, PSC Biotech
Chris Humphrey, Core Team Leader ,CRB
4:30 – 5:30 pm
Registration, Refreshments and Networking
5:30 – 6:30 pm
Presentations: The Principles of Implementing Good Manufacturing Practices (cGMP’s) and Validation of FDA Licensed Facilities
- GMP – current Good Manufacturing Practices
- Design/Build for cGMP
About the Presenters:
Justin Cantor is a Director at PSC Biotech. He was previously the Associate Director of Engineering and has held several positions in Engineering, Maintenance and Manufacturing at Gilead Sciences. Prior to his 12 year career at Gilead, he was a Production Supervisor at Alpha Therapeutics and was a Contract Manufacturing Associate and Clinical Manufacturing Associate at Genentech.
Justin has a MS in Pharmaceutical Manufacturing from Stevens Institute of Technology and a BS in Mechanical Engineering from Michigan State University. He also serves on the ISPE Los Angeles Board of Directors as Vice President.
Chris Humphrey is the Core Team Leader for CRB’s San Diego office. He has 17 years of engineering and project management experience throughout the Southern California life science industry. He works with CRB’s engineers, architects and construction professionals to deliver design, construction and consulting solutions that achieve successes for their life sciences and advanced technology clients. Chris earned his BS in Chemical Engineering from UC-Davis.
Charles Heldebrant, PhD is the Chief Scientific Officer at PSC. He has 28+ years of experience with Alpha Therapeutic Corporation (formerly Abbott Scientific Products Division) and 4+ years of experience with National Genetics Institute/LabCorp. He has extensive experience in biological and pharmaceutical product development, regulatory affairs, quality systems, process design, equipment and process validation, analytical methods validation and computer validations. He has audited and worked with foreign and US development partners to evaluate API and final drug product, process and facilities and has worked to help development partners achieve cGMP compliance. He has experience in nucleic acid based diagnostics and in the operation of 24/7 facilities. He was also a science consultant for an animated science program for pre-school children