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Dallas L. Thomas RAC MHA MPA Certified Lead Auditor
RAC MHA MPA Certified Lead Auditor
Dallas L. Thomas is a seasoned professional in the medical device and pharmaceutical industry with extensive experience in regulatory affairs, quality management systems, and FDA compliance. Here's a comprehensive overview of his background and expertise:
Professional Qualifications
Dallas L. Thomas holds several important credentials:
- Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society4
- Master of Health Administration (MHA)
- Master of Public Administration (MPA)
- Certified Lead Auditor for ISO 13485:2016
- Six Sigma Yellow Belt (SSYB)4
Current Role and Expertise
Thomas currently serves as a Consultant for Pharmaceutical Drug, Medical Device, Science, IVD Manufacture, FDA 483, Regulatory, CGMP, and Audit at IQVIA.3 His areas of expertise include:
- FDA regulatory affairs
- Compliance
- Quality management systems
- Medical device industry regulations
Professional Experience
With 14 years of experience in the medical device industry, Dallas L. Thomas has developed a strong background in various aspects of regulatory affairs and quality management.2 He is known for his work in:
- Navigating FDA submission processes
- Approval procedures
- Post-marketing procedures for various dosage forms and therapeutic areas
- Addressing complex non-clinical and clinical issues
Additional Roles and Affiliations
Thomas is also associated with:
- Thomas Regulatory Resolutions (TRR), where he serves as a Medical Device Consultant1
- Pharmaceutical Development Group (PDG), where he contributes his expertise in regulatory affairs2
Language Skills
Dallas L. Thomas is multilingual, capable of communicating in:
- English
- Spanish (Hablo Español)
- Portuguese (Falo Português)1
Contact Information
For professional inquiries, Dallas can be reached at:
- Email: [email protected]
- Location: (Main Office) Florida, USA1
Dallas L. Thomas is well-regarded in the industry for his ability to assist FDA-regulated firms with regulatory strategies, emergency responses to FDA actions, and long-term product lifecycle management.2
Highlights
2024 will be a year of diverse challenges for MedTech companies, some of which presage potentially significant changes before the decade is over. This insight brief covers ten of the top trends IQVIA MedTech experts see on the horizon and the implications for the MedTech industry. Reach out to us at IQVIA for any of your consulting needs #fda #IQVIA #consultants #FDAconsultants #medicaldevice #medtech https://lnkd.in/e-8NEJDh
Without the right attention to core quality principles, pharmaceutical, biotechnology and medical device companies can be vulnerable to compliance lapses and regulatory enforcement actions. This can be costly, prompting key stakeholder concerns, damage to a company's reputation and bottom line, and interruption of critical drug or device supplies. An organization's ability to quickly adapt to meet increasing regulatory enforcement is paramount to its success — and demands a focus on the global, cultural and regulatory elements of change. In this heavily scrutinized regulatory environment, staying ahead of the curve on quality and regulatory compliance requires a focused, integrated, proactive approach, with the right partner to help you navigate this increasingly complex landscape. #FDA #FDAConsultants #FDA483 #FDAWarningLetter #FDAenforcement #Pharmaceuticals #medicaldevices #lifesciences #manufacturing #medtech
