AUDIT EXPERTISE
QMS PROCESS EXPERTISE
EU Medical Device Directive/Regulations (MDR)
EU In Vitro Diagnostic Regulation (IVDR)
MDSAP
ISO 13485
ISO 9001
21 CFR 820
21 CFR 806
21 CFR 803
21 CFR 210
21 CFR 211
ICH Q7
Premarket:
– Design Control
– Document Control
– ISO 14971/Risk Management
Production:
– ISO 14971/Risk Management – Process Validation
– Production and Process Control
– Supplier Controls
– Document Controls
Post Market:
– ISO 14971/Risk Management – CAPA
– Complaint Handling and Medical Device Reporting
– Supplier Controls
– Document Controls
– Clinical Evalution Reports
– Postmarket Surveillance
– FDA 483 Remediation
– FDA Warning Letter
– FDA Consent Decree
– NB Major Observations
Katie Dale has more than two decades of experience in RA/QA for the medical device, pharmaceutical, and specialty chemical industries, on a global basis. Her expertise includes quality management systems, regulatory compliance, and both internal and external auditing. She is a confident decision maker/problem solver with an understanding of complex issues and the proven ability to implement, coordinate, and complete projects simultaneously.
Katie has supported a wide range of medical device manufacturers to adhere to the new EU Medical Device Regulation and has led the planning and execution of their transitions.
Katie is the lead auditor who has conducted numerous audits and has been an asset to the hundreds of auditors that she has trained and qualified in various regulatory disciplines and approach.
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EDUCATION:
Bachelor of Arts degree in Biology from Niagara University, Niagara Falls, NY
TRAINING & CERTIFCATIONS:
ISO 13485 QMS & Lead Auditor -
AREAS OF EXPERTISE:
Quality Systems and Audit – As Quality Systems Manager (Quality and Regulatory Lead, Medical Device Division) for International Specialty Ingredients, Katie led qualification and site transfer, resulting in a cost savings of more than $100,000 and more than $15M in revenue protection. In addition, she established a medical device changing program, which was delivered to 35 employees. This program generated a 3% reduction in cost annually. Katie managed the internal/external audit program, whose conformance rating resulted in 100% retention of key accounts.Quality Systems and Audit – As Quality Systems Manager for Ashland, Inc. (a $5B specialty chemical company serving the personal care, pharmaceutical, nutrition, and industrial segments), Katie was the global lead for the organization’s key performance indicators (KPIs) and strategic dashboard for monthly performance reporting to the Board of Directors and Executive Leadership. She drove global conversion from a predicate system to a quality information management (QIM) system for consistency in process for managing/resolving customer complaints related to product and service quality.
She developed a train-the-trainer program and led an 8-person Global Logistic Team that sustained the complaint process while driving improvements throughout the organization. Katie was recognized by the company’s Quality and Regulatory Leadership as the company’s principal Medical Device Subject Matter Expert, ensuring the divisions continued compliance.
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