110 E. 22nd Street,Warehouse 9
San Pedro, CA 90731
a Craft Brewery Featuring Belgian Style Beers
Session 1: 4:00 - 4:30 pm
Improving Product Quality During Technical Transfers
Speaker: Eric S. Good, PhD, Director, Compliance
Services, ProPharma Group
About the Speaker:
Dr. Good is an energetic leader with extensive U.S. and international manufacturing, project management, consent decree and quality systems experience with Fortune 500 Companies. He has 28 years of experience in biotech, pharmaceuticals and animal health. He is a recognized expert in operations, project management and quality. He is an active leader in large and small organizations with operational and compliance challenges. His strengths are complex systems integration and implementation, process improvement, and crossfunctional working relationships.
Session 2: 4:45 - 5:45 pm
Keynote Presentation: What’s New in ISPE
Overview from Headquarters and Amgen perspective
Tim Howard, 2018 ISPE Board of Directors Chair, VP Commissioning Agents Inc.
Nick Haycocks, Corporate Quality, Amgen
Tim will discuss the following:
ISPE Initiatives and Membership Benefits
ISPE is moving locations this year
The Bethesda Office will Include a Training Facility
Updated Training Strategy
Guide Docs OnLine
Improvements to Pharmaceutical Engineering Magazine
New Guides in Development
Nick will Present:
ISPE Guidance Documents Update
How do Guidance Documents get Produced?
Update on Upcoming Documents
About the Speakers:
Timothy P. Howard, CPIP, PE, is a VP of Strategy and Development at Commissioning Agents, Inc. and President of DataVoke, Inc., a wholly owned software company of Commissioning Agents, Inc. Tim has been on International Board of Directors at ISPE since 2011, and is currently Chair. He was a member of the ISPE Task Team that developed the ASTM standard E2500 and a contributing author to ISPE Guidance Documents on ASTM E2500 Implementation. He is a qualified trainer for the ISPE training course on C&Q applications, regularly speaks at conference seminars worldwide, and is published in Pharmaceutical Engineering. Tim previously worked with Eli Lilly, is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. He earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional, and a licensed Professional Engineer in North Carolina.
Nick Haycocks is a Senior Engineer in Corporate Quality at Amgen Inc. Previously he has worked for Schering Plough and GSK in Engineering and Project Engineering roles. Nick has been involved in ISPE Guidance Documents development and committee task groups for many years. He has been on the ISPE LA Board, and currently is active on the ISPE LA Program Committee.
Meet Suppliers and Service Providers ready to help your company soar to the next
Our 3rd Year:
This will be our 3rd year at this local Craft Brewery that features Belgian style beers,
located in San Pedro.
$20 Entrance fee includes:
1 Food Truck Meal Ticket
12:30 - 2:00 pm Exhibitor Set Up
2:30 - 8:00 pm Exhibit Show Open
4:00 - 5:45 pm Technical Session