Data Integrity – Beyond Good Documentation Practices … ASQ Biomedical NCDG August 23, 2017 Roundtable

Data Integrity – Beyond Good Documentation Practices … ASQ Biomedical NCDG August 23, 2017 Roundtable
Data Integrity – Beyond “Good Documentation Practices”A small company view to creating a culture of compliance Wednesday, August 23, 2017, 7:00 to 9:00 pm   Topic: 21CFR11.3(b5) requires that "the integrity of the data can be verified". 21CFR820 has 10 references to ”data” 21CFR820.180 requires data "made readily available…legible…stored to minimize deterioration and loss…backed up”. ISO 13485(2016) has new requirements for “data analysis”, to “protect” “confidential…information” Data, whether captured in paper or electronic format, is the basis for product assumptions and decisions from the manufacturing floor to the boardroom to the offices of regulators and notified bodies.  Medical Device companies, especially small start-ups, often limit discussions of data integrity to “Good Documentation Practices”.  GDP is a set of widely accepted, unwritten rules, dealing with the collection of data during design and manufacture of a product, mostly focused on paper based systems, where “data integrity” refers to the completeness, consistency, and accuracy of all data.  Validations of electronic systems that collect and store data and management of paper-based systems can be daunting to resource-constrained companies.  Before the protocols, quality professionals should start with a “culture of compliance” based on ensuring a common understanding of the significance of managing and maintaining product and design data at all stages of the product lifecycle.     Featured Speaker:           Brian McCollum, Vice President, Quality, Apama Medical, BS Aerospace Engineering, MBA, CQA, CQE.  Brian has over 20 years experience in Medical Device Quality Management ranging from large multinational commercial organizations to small pre-clinical start-ups. Brian was one of the long-term members of the Northern California Biomedical Discussion Group in the years 1998-2010, and served in various roles, including Communications, and Arrangements.   Moderator: Barry Craner, former Vice President of Quality and Regulatory, Stellartech Research Corporation. Location: Stellartech Research Corporation, 560 Cottonwood Dr, Milpitas, CA 95035  Food:  Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.  Email: To be added to or removed from our email list, contact George Marcel ( Registration Link: ONLY Check or Credit Card (log in online to Eventbrite) accepted at door Questions:  For information about this session, contact Barry Craner (    Formal discussion and questions will end between 8:30 – 8:45 pm to allow time for networking after the roundtable presentation. Materials: Handouts provided. Please limit distribution to immediate personal professional use only. _____________________________________________________ If you cannot attend in person or are outside Northern California, join us online…. Webinar Link Option for  August  Roundtable  (Note: No fee charged – go to link provided to log in) Remote Access Note: Presentation Materials or RU credits not provided at this time.  _______________________________________________________   

at Stellartech Research Corporation
560 Cottonwood Drive
Milpitas, United States

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