Regina Fullin
Validation Consultant at Compliance Team, Inc.
Regina Fullin is the Director of Compliance Consulting Services at Compliance Team, Inc. (CTI), where she assists clients in the medical device and pharmaceutical industries to help them achieve ever-increasing compliance to regulations in the Pharma, medical device, and related industries. She began her career more than 20 years ago in a Quality role at Abbott Laboratories, and has worked in Quality roles at other companies, including GE Healthcare. Her particular areas of expertise focus on validation, equipment qualification, complaint handling, technical writing and remediation projects for companies requiring compliance assistance. Within her role at CTI, Regina also uses her writing skills to publish relevant and meaningful articles to help medical manufacturers stay current with regulatory changes, industry trends and improve product quality.

Regina is active in the American Society for Quality (ASQ), an international non-profit organization devoted to serving the needs of quality professionals. Regina is active in the Northeastern Illinois Section (1212) as Past Chair. In addition to her Section involvement, Regina also serves on the ASQ Food, Drug and Cosmetic Division, where she participates in conference/event planning and annual audit. Regina is also a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.
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Recorded Webinar
The Best Way to Develop or Improve a Master Validation Plan
Validation Master Plans (VMPs) are written to guide and implement an organization with its validation strategy. The Validation Master Plan is different from a validation procedure (SOP), which describes the WHY for performing validation activities. The VMP describes the WHERE and HOW of a process validation program.
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Technical Writing for Medical Products: SOPs, Investigations and Change Records
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
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Process Validation for Medical Device Compliance
The FDA finds inadequacies in process validation with Medical Device firms frequently. In fact, the fourth most frequently-cited Form 483 observation for medical device firms is for Process Validation. Find out how you can avoid these observations and emerge from your FDA audit with zero observations! Medical device validation can be confusing, but this webinar will clear many of the misconceptions related to process validation for medical device companies and helps you to bring your validation program to ship-shape!
Recorded Session Get life time access for one participant with download option!

Technical Writing for Medical Products: SOPs, Investigations and Change Records
This webinar will focus on effective communication of technical information so that an external auditor will quickly understand it and credit your organization with doing the job right.
Recorded Session Get life time access for one participant with download option!

Process Validation for Medical Device Compliance
The FDA finds inadequacies in process validation for Medical Device firms at an alarming frequency. In fact, the fourth most frequently-cited Form 483 observation for medical device firms is for Process Validation. Find out how you can avoid these observations, and emerge from your FDA audit with zero observations! Medical device validation can be confusing, but this webinar will clear many of the misconceptions related to process validation for medical device companies, and help you to bring your validation program to ship-shape!
Recorded Session Get life time access for one participant with download option!

Enhancing your CAPA Program by Developing a Learning Organization
This Webinar provides tools needed to sell a meaningful CAPA program up to Management, by discussing how CAPA can be used as a tool to yield business results. This well-researched webinar references classic business literature, written by famous business minds, such as Peter Drucker and Peter Senge, to describe how a CAPA program appeals to the needs of Knowledge Workers in a Learning Organization, CAPA therefore becomes a business tool to un-learn behaviors that are thwarting progress in the organization, and becomes a tool for sustainable change, organization alignment and business risk management.
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Cold Chain: GDP Guidelines, Audits and Regulations
This webinar will provide the attendee a brief overview of U.S. and European requirements for Good Distribution Practices (the new GDP), along with a discussion of the types of risks to anticipate in a pharmaceutical supply chain. The webinar will go on to describe how to go about identifying and mitigating the risks, identify appropriate techniques to use for mitigating supply chain risks, and finally, to describe some of the tools at one’s disposal to prepare for an audit of one’s supply-chain program.
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The New Validation Paradigm: Are you Ready for Annex 15 Eudralex Volume 4: On the 1st of October?
Annex 15 of the European Commission (Eudralex) Volume 4 on Qualification and Validation has undergone a significant rewrite, effective on October 1, 2015.
Recorded Session Get life time access for one participant with download option!

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