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ISPE Documentation Surrounding GMP Facilities and Processes: The Real (and Sometimes Not-So-Real) Expectations

Apr 19, 2012, 5:30 PM to 8:30 PM

The Time, Money, Value, Quality, Safety. These variables all describe the amount of documentation required when specifying, engineering, building, and operating GMP facilities. This program will investigate and provide open forum discussions on what each department involved in delivering and operating quality systems for GMP facilities expects as the minimum documentation requirements and why. In doing so, we will investigate the blurring lines between commissioning and qualification. We will also look at the real value that comes from spending countless hours developing, reviewing, and final approval cycles of the finished document and possible ways to remediate the process. 

The program is designed to provide insight to all members of the delivery and operations team including operations, manufacturing, quality, validation, and vendors.

Chris Ames, Director Quality Assurance Validation, Genzyme
Chris Ames is currently the Director of Quality Assurance Validation for Genzyme Allston joining in September 2011.  His group is responsible for the QA oversight for all validation activities on the site. Previously, Chris held corporate Validation Director roles at both Hospira and Catalent Pharma Solutions. His experience covers more than 20 years in quality and validation starting as a Validation Engineer and progressing through roles of increasing responsibilities at Schering Plough and Hoffman la Roche before moving to Catalent Pharma Solutions.

Rob Beane, Regional Manager - Compliance, IPS (Integrated Project Services)
Rob has over 14 years of experience in managing and leading commissioning and qualification efforts in the pharmaceutical, biotechnology, and medical device industries. Mr. Beane has experience in validation planning, project management, automation validation, computer system validation and process validation, and is currently serving as Regional Manager, Compliance for Integrated Project Services (IPS). Rob has assisted clients with the implementation of science and risk-based approaches to compliance to align with the ISPE Baseline Guide for Commissioning and Qualification and ASTM Standard E2500, including compliance projects up to a budget of $5MM. Rob is a member of ISPE and PMI.

Mike Marino, Sr. Quality Engineer Corporate Quality Systems, Boston Scientific
Mike is a Project Manager within the Global Facilities Organization for Boston Scientific with 25 years in both Facilities system design and Quality Assurance for GMP manufacturing (pharma and device). Mike is the Corporate SME for BSC’s Controlled Environment manufacturing qualifications. In this role Mike is responsible for all Commissioning and Qualifications on new construction and renovation projects for Corporate Facilities. Specifically clean manufacturing suites and controlled environments, sterilization facilities, and warehouse and distribution centers. His responsibilities include providing the corporate guidance in quality systems regulations (QSR) and compliance to the site’s project teams, manage commissioning consultants, plus integrate the Quality Systems to Facilities projects. He is also responsible for adherence to agency regulatory requirements, ISO standards and guidance’s to the commissioning and validation of critical utilities systems. Mike serves on a corporate committee for ISO review and standards implementation.

Dave Mitchell, Senior QA/QC Lead, Cotter Brothers Corp
Dave and is a current AWS (CWI) Certified Welding Inspector for over five years. Dave has been responsible both directly and in support of the documentation requirements that are incorporated in all of the project Turn Over Packages supplied to end users. He has been performing inspections and supplying documentation to the Cotter Brothers Corporation for over eight years and has over ten years experience in the industry

Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

Before 04/12/2012:
Members $50
Non Members $95*
Student Members $5

After 04/12/2012:
Members $60
Non Members $115*
Student Members $10

* Join ISPE now and pay the Member rate. Join within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information. 

Royal Sonesta, Cambridge, MA


Page last updated: 4 May 2011