ISPE San Diego Chapter Quality by Design and Compliance Meeting

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1 ISPE San Diego Chapter Quality by Design and Compliance Meeting 4:30-7:45 pm Sponsored by: CRB Location: CRB 3207 Grey Hawk Court, Suite 150 Carlsbad, CA Program Managers: Rod Freeman, Global Process Owner - Process Validation, Beckman Coulter Emily Nelson, Project Manager, San Diego Area Lead, Azzur Group Nicki Lange, Pacific Business Liaison, Commissioning Agents Inc. (CAI) Speakers: Cheryl Bondurant, Senior Compliance Consultant, Commissioning Agents Inc. Rod Freeman, Global Process Owner - Process Validation, Beckman Coulter Matt Romey, Project Manager, Medical Device Division, Azzur Consulting David Sisto, President/CEO, Purity Systems Inc. Schedule: 4:30 5:30 pm Registration and Social Hour with Appetizers and Craft Beer (sponsored by CRB) 5:30-7:45 pm Presentations Cheryl Bondurant - Design and Development with Quality Embedded - First Time Right Approach Rod Freeman Building a Quality System to Support LEAN Manufacturing Matt Romey The Parallels between Quality by Design and the Design Control Methods Used by the Medical Device Industry to Ensure Quality in Product Development David Sisto 3rd Party Inspection, Codes and Standards, Orbital Welding, Inspection and Examination, Documentation and Certification Thank you To Our 2016 Sponsors Platinum Gold Silver

2 Quality by Design and Compliance Meeting About the Speakers Cheryl Bondurant, Senior Compliance Consultant, Commissioning Agents, Inc Cheryl has 35 years of experience working in FDA and ISO regulated environments. She has implemented effective compliant quality systems for medical devices, biologics, in-vitro diagnostics and electronics. Cheryl is currently working as a Senior Compliance Consultant for Commissioning Agents helping clients with inspection readiness, compliance gap assessments and building quality systems. Previously she spent 11 years at HemCon Medical Technologies in Portland, OR as the Director of Quality ensuring product quality through the establishment, enforcement, monitoring, and reporting of Quality System compliance to 93/42/EEC, ISO 13485, and 21CFR Part 820. Cheryl is an instructor of FDA regulations and ISO standards and implementation. She taught for 3 years at the Portland Community College as a Professor of Quality Systems for Bioscience & Applied Quality Practices, where she planned, created, and taught course content for the understanding and implementation of Quality Management Systems and quality product in a regulated environment. Cheryl will have a hands on, fun and interactive workshop where participates will learn how to embed Quality into the design during the development of product and carry it through to manufacturing. By following FDA Regulations for design control, participants will learn how to get it right the first time and prevent the need for timely and costly redesign. Rod Freeman, Global Process Owner - Process Validation at Beckman Coulter. Mr. Freeman has over 20 years experience supporting manufacturing operations in the cgmp regulated Life Science Industries. He is currently the Manager of Validation and Calibration at Beckman Coulter in Carlsbad, CA, and is also the Global Process Owner for Process Validation for all of Beckman. He has held roles of increasing responsibility in Validation, Facilities Management, Project Engineering, and Quality Systems in firms including Pfizer, Abbott, Eli Lilly, and Teva. He has extensive expertise in Pharmaceutical Water System design, operation, and maintenance, and serves as the Secretary for the International Society for Pharmaceutical Engineering (ISPE) Critical Utility Community of Practice, where he is participating in the revision of the Critical Utility C&Q Guide, and the drafting of the Critical Utility Sampling Guide. He previously assisted in the drafting of the ISPE Good Engineering Practice Guide. He also holds the position of Past President on the ISPE San Diego Chapter Board of Directors. Mr. Freeman holds a B.S in Chemical Engineering from Virginia Tech, is a Certified Project Management Professional through the Project Management Institute (PMI), and is currently pursuing a M.S. in Regulatory Affairs from The Johns Hopkins University. Mr Freeman will discuss Building a Quality System to support LEAN manufacturing: A dynamic LEAN manufacturing environment is continuously improved through incremental changes and improvements to materials, equipment, and processes. In the FDA regulated environment this can seem at odds with the requirements typically imposed by our quality systems. This seminar will discuss how to proactively structure your quality system to support a LEAN environment while also maintaining compliance. Matthew Romey, Project Manager, Medical Device Division, Azzur Consulting. Mr. Romey is a chemist, engineer and entrepreneur with almost 25 years of experience in the medical device industry. He is currently leading the Medical Device Division at Azzur Consulting, providing engineering and business consulting to medical device firms. His expertise in the design and development of medical technology spans from demonstrating technology feasibility to executing on product design and getting products to market. Before Azzur, Mr. Romey was a founding employee at GluMetrics, an Irvine start-up company focused on developing a continuous glucose monitor for hospitalized patients. Before GluMetrics, he worked at Terumo Cardiovascular and 3M Healthcare in various scientific and engineering capacities. He is a Certified Quality Engineer and a Certified Project Management Professional. He graduated with a B.S. degree in Chemistry from the University of California, Berkeley, and earned an MBA degree from the Paul Merage School of Business (University of California, Irvine). David Sisto is the President and CEO of Purity Systems, Inc, an independent third party quality assurance and analytical testing service company. Purity services the microelectronics, pharmaceutical, healthcare, biotechnology, aerospace, semiconductor, OEM and food and beverage industries. For over 25 years, Purity's inspection and analytical testing technicians, engineers and documentation specialists have guaranteed the success of high purity.

3 Registration Instructions ISPE San Diego Chapter To Register and Receive an immediate receipt, use our on-line registration: ISPE LA, SD, SF Members: If you are an ISPE Member in California, please do not set up a new account, as you should already be in our system. If you do not know your username or password, please Rob Fleming (rob.fleming@yahoo.com) for assistance. ISPE Members of other Chapters: You will not be in our system unless you have previously set up an account. Please follow instructions for Non Members below. To update your account to a Member account, please forward your confirmation from ISPE or ISPE Membership Card to Rob Fleming (rob.fleming@yahoo.com). We need your Chapter name, your ISPE Member number and expiration date. You can get your Membership card once logged onto the ISPE website (see bottom left side of the screen). Non Members: If you do not have an account on our system, you can set one up on the site using letters (not numbers) as your username. If you need help setting up your account or if you are having problems with the site or need a new password, please Rob Fleming (rob.fleming@yahoo.com) for assistance. Registrations can also be faxed. Complete the form and fax to If paying by check, please mail your check made payable to: ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641, Irvine, CA (949) ISPE San Diego Chapter Tax ID# Registration Fees: Free for CRB Employees ISPE Members $60 Non Members $90 Students $30 Sponsors $500 (includes table and two attendees) Registration or Online Questions? Contact Rob Fleming: rob.fleming@yahoo.com Any other Questions, Contact Kimberly Syre: ksyre@cox.net Name Badges will be given at the event Cancellations must be received via to: ksyre@cox.net by May 17, 2016 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your place. If the alternate is not a member, they will need to pay the additional amount for non-members. Name Badges will be given at the on-site registration desk.

4 Quality by Design and Compliance Meeting Registration Form REGISTRATION RATES $60 ISPE Members $90 Non-Members $30 Students $500 Sponsors FREE for CRB Employees Sponsors: Your fee includes a 6' Table Top Display and Two Attendees to the meeting. Please supply the name and addresses of your attendees: CREDIT CARD PAYMENT - Please Indicate Type of Credit Card VISA MASTERCARD AMERICAN EXPRESS Name on Card Signature: Credit Card #: Exp Date: YOUR CONTACT INFORMATION: First and Last Name: Title: Company: Address: City: State: Zip: Phone: Fax:

5 Driving Directions: CRB 3207 Grey Hawk Court, Suite 150 Carlsbad, CA From Downtown San Diego Take I-5 North Take the La Costa Ave exit, EXIT 44Take the La Costa Ave, Exit Turn Right onto La Costa Ave. Turn Left onto El Camino Real Turn Right onto Palomar Airport Rd Turn Left onto Eagle Dr. Take the 1st Right onto Grey Hawk Ct. Destination will be on the Right From North San Diego County Take I-5 South Take the Palomar Airport Exit Turn Left onto Palomar Airport Rd. Turn Left onto Eagle Dr. Take the 1st Right onto Grey Hawk Ct. Destination will be on the Right It is recommended that you look up directions from your starting point to make sure you have the best driving directions.

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