- 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.”
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.
- 12:30 – 2:30 pm
- 2:30 – 3:30 pm Event Begins
- 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.
- 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
- 5:30 – 7:00 pm
- 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
- 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