Barbara Alspaugh
Regulatory Specialist at DePuy Synthes Companies | Mechanicsburg, Pennsylvania, United States
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Barbara Alspaugh serves as a Regulatory Specialist at DePuy Synthes Companies, where she leverages her extensive 18 years of experience in the highly regulated Biologic Pharmaceutical and Medical Device Industries. Her role is pivotal in ensuring compliance with stringent regulatory requirements, particularly in the realm of post-market surveillance. Barbara is adept at managing adverse event reporting and device malfunction submissions, navigating the complexities of US, EU, and OUS Medical Device Report and Health Authority Vigilance submissions with precision and timeliness.
A key aspect of her responsibilities includes the preparation and submission of Medical Device 3500A forms and Health Authority EU Reports, ensuring that all submissions meet the required agency timelines. Her substantial experience in regulatory reporting, particularly with ISO 9001, ISO 13485, ISO 14971, and ISO 14001 standards, positions her as a critical asset in maintaining the highest quality and safety standards for medical devices. Barbara's expertise extends to Quality Control (QC) and Quality Assurance (QA), where she applies her knowledge of Good Manufacturing Practices (GxP), aseptic processing, and environmental monitoring to enhance product integrity.
Barbara's proficiency in utilizing tools such as Trackwise for document management and her experience in technology transfer further underscore her capability to streamline regulatory processes. Her commitment to excellence and her comprehensive understanding of the regulatory landscape make her an invaluable contributor to DePuy Synthes, where she plays a crucial role in safeguarding patient safety and ensuring regulatory compliance in a rapidly evolving industry.
Regulatory Specialist at DePuy Synthes Companies in May 2019 to Present
External Quality Batch Release Coordinator, COVID-19 at The Janssen Pharmaceutical Companies of Johnson & Johnson in November 2020 to April 2022
Customer Quality Specialist-Regulatory at DePuy Synthes Companies in July 2015 to November 2018
Sr. QA Associate at The Janssen Pharmaceutical Companies of Johnson & Johnson in January 2012 to June 2015
Quality Control Scientist-Lead at The Janssen Pharmaceutical Companies of Johnson & Johnson in January 2009 to December 2011
Quality Control Scientist at The Janssen Pharmaceutical Companies of Johnson & Johnson in July 2004 to December 2008
Biology Technician at Merck in November 2002 to July 2004
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West Chester University of Pennsylvania, Bachelors of Science, August 1998 to August 2026
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Microbiology
Quality Assurance
cGMP
LIMS
SOP
QC
Cell Culture
CAPA
Sop
GMP
Biopharmaceuticals
Biotechnology
Quality Control
Environmental Monitoring
Validation
Pharmaceutical Industry
Laboratory
Aseptic Processing
Vaccines
GLP
V&V
21 CFR Part 11
FDA
Change Control
GxP
Trackwise
Aseptic Technique
Technology Transfer
U.S. Food and Drug Administration (FDA)
Verification and Validation (V&V)
Corrective and Preventive Action (CAPA)
Laboratory Information Management System (LIMS)
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Discover more about DePuy Synthes CompaniesWhat is Barbara Alspaugh email address?
Email Barbara Alspaugh at [email protected] and [email protected]. This email is the most updated Barbara Alspaugh's email found in 2026.
How to contact Barbara Alspaugh?
To contact Barbara Alspaugh send an email to [email protected] or [email protected]. (updated on August 25, 2024)
What company does Barbara Alspaugh work for?
Barbara Alspaugh works for DePuy Synthes Companies
What is Barbara Alspaugh's role at DePuy Synthes Companies?
Barbara Alspaugh is Regulatory Specialist
What is Barbara Alspaugh's Phone Number?
Barbara Alspaugh's phone (215) ***-*129
What industry does Barbara Alspaugh work in?
Barbara Alspaugh works in the Pharmaceuticals industry.
Barbara Alspaugh Email Addresses
Barbara Alspaugh Phone Numbers
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