JAN 13 6:30 - 8:00 pm Practical Application of Document Control Requirements

Published
Document control forms the backbone of Quality Systems from cosmetics to pharma to
devices. Although the regulations applicable to each industry varies, the purpose of
document control remains constant – to ensure reproducibility and traceability. This
presentation includes a detailed breakdown of a document control program including
the regulatory requirements and how those requirements are translated into practice.
 Fundamental requirements of a document control program
 Best practices for effective implementation and management of a
document control program
 Examples of actual procedures, forms and process flow charts
 Good documentation practices
 Training as a function of document control
 Document control trends
 Lessons learned from FDA inspections
 
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Speaker bio:
Erica Livingston RAC, has been working in biotech for over 20 years including 12
years in Quality Assurance. Erica has a B.S. in Biology from UCSD and spent 10
years at the bench doing molecular biology product development at The Salk
Institute, Johnson & Johnson, Hologic, and Trinity Biotech, among others. Erica
uses her bench experience to help develop the operational processes that make
up the Quality System. Erica specializes in right-sized Quality System
implementation and optimization for small and start-up medical device
companies. She founded Qualomics LLC in 2014 with an appreciation for the
unique challenges that start-ups face working in a regulated field. Her work
includes design control, late-stage development and transfer to manufacturing
under ISO 13485 and 21 CFR part 820 for IVDs, orthopedics, women’s health
products, cardiology, nephrology and oncology products. In addition, Erica has
experience with GLP, CLIA/CAP, and tissue bank regulations. Erica received her
Bachelor’s of Science in Biology from University of California, San Diego. She
holds certificates for auditing in verification and validation, ISO 13485, 14971
and the MDSAP audit model.Erica earned the US Regulatory Affairs Credential
from RAPS in 2017.
News Palomar Section 01/10/2021 10:25am CST

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