Tag Archives: ISPE Los Angeles

ISPE LA GMP Expo & Exhibit Show

  • State of the Art Biopharmaceutical Manufacturing 3:30 – 4:30 pm
  • Preparing for an FDA Facility Audit 5:30 – 7:00 pm
  • Just added:  Dr. Raymond Brullo “Preparing for an FDA Inspection: A Compliance Officer’s Perspective.”
Thursday, May 26, 2016
Brouwerij West
A Newly Opened Brewery in 
San Pedro
110 E. 22nd St. Warehouse No. 9 San Pedro, Ca 90731 
Plenty of Free Parking
Experience bioprocessing in action and join us at Brouerji West, a new brewery in San Pedro, Belgian-inspired ales made in a 72-year-old wooden warehouse in the port of Los Angeles. Technical sessions take place in the area next to exhibits, please keep the noise levels down during the sessions.
Please download our  free ISPE Los Angeles Chapter App:   you will find powerpoints from the presentatations here in the Speakers section

It is thanks to the generous sponsorship of our exhibitors that we are able to offer such a high-quality program at such a value, please visit their links in the exhibitor tab. 

Questions?  email  ispelosangeles@gmail.com
Schedule:  
  • 12:30 – 2:30 pm
Exhibitor Set Up 
  • 2:30 – 3:30 pm  Event Begins
Attendee registration and networking in Exhibit Area – come see what’s new for your cGMP-compliant facility
  • 3:30 – 4:30 pm  

State of the Art Biopharmaceutical Manufacturing in the Developing World

  • Speaker: John M. Hyde, Chairman and Founder, Hyde Engineering + Consulting, Inc.
  • Program Manager: Chris Wilkinson, Regional Manager, Southern California, Hyde Engineering + Consulting, Inc.
  • Synopsis:
    • This Session will Feature Case Studies: New, compliant facilities that minimize capital and operating costs while maximizing manufacturing efficiency Biopharmaceutical products offer uniquely effective treatments for serious disease conditions. For economic reasons, these drug products have typically only been available to patients in developed countries, but demand is growing in developing countries as their economies expand at relatively rapid rates. This growing demand is being addressed by in-country manufacture of biopharmaceutical products at costs that make treatments accessible to the growing middle classes in the developing world. Biopharmaceutical manufacturing facility case studies will be presented, highlighting strategies and methodologies for minimizing capital cost and construction timelines and maximizing operational efficiency. Cost saving and efficiency maximizing techniques, including the utilization of single-use components, modular construction, islands of automation, flexible and efficient process system configuration, will be discussed. The session will specifically address: • Design bases for new biopharma manufacturing facilities in the developing world • Strategies and methodologies for minimizing capital cost and construction timelines • Maximization of operational efficiencies for minimization of cost of goods • Role of single use components and modular construction • Automation strategies that maximize operational flexibility while minimizing complexity and costs
  • About the Speaker:
    • John Hyde founded Hyde Engineering + Consulting in 1993 to serve the Pharmaceutical and Biopharmaceutical community. Prior to the formation of Hyde Engineering + Consulting, John was a Senior Project Engineer with a biopharmaceutical research and manufacturing company located in Boulder, CO. His work included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm’s large scale and clinical manufacturing facilities. From 1982-1993, John was Manager, Process Systems Design with an engineering firm specializing in the design and start-up of pharmaceutical, dairy and food process systems and the application of CIP technology. John has published and presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, cleaning and cleaning validation principles and practices, FDA compliance strategies, and control systems design for manufacturing processes. John served as a member of the PDA Subcommittee for Biopharmaceutical Cleaning validation and in this capacity he contributed two chapters to “Cleaning and Cleaning Validation, Volume 3”. John serves on the board of the Society of Bioprocess Professionals (SBP) and is a regular speaker at conferences sponsored by SBP, ISPE, PharmaConference, IVT, Microrite and other professional societies. He holds bachelor’s degrees in Food Science and Business Administration and a master’s degree in Food Engineering from Ohio State University.
  • 4:30 – 5:30 pm
Break in Exhibit Area   
  • 5:30 – 7:00 pm
Preparing for an FDA Facility Audit
  • Speaker: Vincent J. Cebular, Principal and Senior Vice President of Compliance, Integrated Project Services (IPS)
  • Speaker:  Raymond W. Brullo, DPM, Compliance Officer, Office of Regulatory Affairs, FDA Los Angeles District
  • Program Manager: Margaret Stava, cGMP Laboratory/Facilities Equipment Specialist, Laboratory Equipment Company
  • Synopsis:
    • The presentation will begin with a presentation by Dr. Raymond Brullo “Preparing for an FDA Inspection: A Compliance Officer’s Perspective.
    • Following will be Vincent Nebular who will focus on how to prepare for a successful PAI (Pre-Approval Inspection) for newly constructed and/or renovated facilities. The approach will follow the FDA’ Six-System Inspection Model with an emphasis on the engineering aspects of Facilities and Equipment Systems and Production Systems. The session will highlight the cGMP requirements throughout a project lifecycle leading up to and supporting a facility inspection. It will include recommendations for interacting with the FDA and planning/ conducting Pre-operational Reviews of Manufacturing Facilities (FMD-135). Following a successful plan review, the presentation will progress throughout the project and culminate with the facility inspection / PAI.
  • About the Speakers:
    • Dr. Raymond W. Brullo, D.P.M. is a Compliance Officer for the FDA/Office of Regulatory Affairs (ORA) in the Los Angeles District Office. Ray has a B.S. degree in Biology from Loyola University of Chicago. He is a D.P.M., Doctor of Podiatric Medicine from Rosalind Franklin University of Medicine and Science. Ray was previously a Biologics, Bioresearch Monitoring and Medical Device Investigator.
    • Mr. Cebular is a principal and the Sr. VP of Compliance at Integrated Project Services (IPS). IPS is an industry leader in providing full-service engineering, integrated EPCMV, construction management, project controls, commissioning, validation, and regulatory consulting services to the pharmaceutical, biotech, health care, and specialty manufacturing industries. Vince has over twenty five years of experience in cGMP consulting, engineering, commissioning, and validation of capital projects within the pharmaceutical, biotech, medical gas, and medical device industries. He has a broad range of experience in the areas of bulk drug manufacturing, aseptic processing, solid dosage manufacturing and packaging, vivariums and R&D laboratories. At IPS, Mr. Cebular’s primary responsibilities include leading the day-to-day compliance operations, performing facility audits and design reviews, working with department leaders to promote efficiency and quality work practices, and conducting internal and external training on technology advancement and innovative methodologies.
  • 7:00 – 8:00 pm
Reception  with appetizers, student poster contest
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Current State and Challenges of the Pharmaceutical Industry, Speakers from Baxalta, Prolacta, Avid Bio

Building an Advanced Global Reliability Program

Shawn Ansari, Sr. Director, Head,Engineering Operations, US/Singapore, Baxalta

 

The Power of Human Touch
Prolacta introduction, history of leadership in Human Milk Science, product overview, clinical evidence, production process.

Joe Fournell, VP, Operations, Prolacta Bioscience®

Biologics Manufacturing: Single Use Systems

Steve King, CEO Peregrine Pharmaceuticals Inc. and Avid Bioservices

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10/8 Agensys Program: Establishing a Quality Risk Management System(QRM) for Drug Development

Establishing a Quality Risk Management System (QRM) for Drug Development

      

Thursday, October 8, 2015
5:45 pm- 8:00 pm  (Speakers begin at 6:30)

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Applying ASTM E2500

On October 23rd, ISPE LA held a program about Applying ASTM E2500.

Phil Bowles, Director of Engineering at Amgen Inc., talked about the journey towards a fully mature risk-based approach for commissioning and qualification of equipment and facilities.

Mr. Bowles spoke about the industry’s risk-based approach based on the ASTM E2500 Guide. He explained that ASTM E2500 is a Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. It provides a science (ICH Q8) and risk (ICH Q9) based approach to assure that GMP equipment & systems are fit for use, perform satisfactorily, and may be used in the manufacturing, processing, packaging, and storage of a drug. It applies the concept of critical quality attributes and calls for the use of subject matter experts (SMEs) to make critical determinations, and redefines roles for Quality and Technical SMEs. It allows flexibility so that the company determines the methodology.

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Particle Monitoring for Aseptic Pharmaceutical Manufacturing Guidance

Particle Monitoring 

for Aseptic Pharmaceutical Manufacturing Guidance

Wednesday, January 21, 2015

3:30-6:30 pm

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Evening with Industry Executives

 Evening with Industry Executives

Current State and Challenges of the Pharmaceutical Industry and

ISPE LA’s 20 Year Anniversary Party

Thursday, November 20, 2014

4:00-8:00 pm

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Learn about Applying ASTM E2500: Improving Robustness and Streamlining Project Delivery Through Science and Risk-Based Commissioning and Qualification

October 23rd, 2014

Program Managers:

Paul Crissman, Biotechnical Solutions

Dona Tseng, Sr. Principal Engineer, Baxter Healthcare

Location:

Baxter Healthcare, 4501 Colorado Blvd., Building 6

Los Angeles, CA 90039

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Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products

On August 20th 2014, the ISPE LA/OC APICS joint meeting was held, covering Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products.

Jason Daoust of Masy Systems discussed validation dataloggers, including their trends, considerations, and options in use today.

He presented an overview of how environmental mapping equipment has evolved and how the industry acceptance of validation dataloggers has increased significantly in recent years. Even though no perfect validation datalogger exists today, most major and minor companies are realizing their benefits. There is a wide variety of loggers for specific applications such as temperature ranges and probe types, and each system has trade-offs. Standalone validation dataloggers vary in temperature ranges (anywhere from -200C to 400C+), humidity ranges (typically anywhere from 0% to 95%), pressure (typically 0 to 72.5 psia) and time.

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16th Annual Golf Tournament

16th Annual Golf Tournament

September 18, 2014

Golf

 

Location:    

Coyote Hills Golf Course

1440 E. Bastanchury Road

Fullerton, CA 92835
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