Are you ready for your next FDA inspection or Notified Body audit⁉️
As a former FDA Investigator with 30-years of industry expertise, I prepare my medical device and IVD clients to be ready for their next FDA inspection and Notified Body audit in the areas of compliance, quality assurance, and quality systems.
⭐️ 30 years of experience in the creation, maintenance, remediation, and auditing of quality system and technical documentation for sterile and non-sterile medical devices and in vitro diagnostics (IVD) to ensure compliance with domestic and international quality and regulatory requirements.
⭐️ Support my clients by providing expertise in building, training, leading, and motivating high-functioning quality and regulatory compliance teams ensuring lasting knowledge transfer and inspection readiness.
⭐️ Talented internal and supplier auditor having practical experience with FDA inspection techniques, Quality System Regulation (QSR), and on-site inspection procedures.
⭐️ Proficient in European and Global quality system standards such as ISO 13485, ISO 14971, ISO 9001, and the EU Medical Device Regulations (MD/AIMD, IVD) and associated Technical Documentation.
⭐️ Work extensively with contract design and manufacturing organizations (CDMO) to ensure that product is designed and manufactured in compliance with client, US, and international quality system requirements.
⭐️ FDA-483, Warning Letter, and Consent Decree responses and overall compliance.
Areas of Expertise:
FDA Regulations / QSR
ISO 13485 Quality Management Systems
FDA Inspection Procedures
Quality System Inspection Technique (QSIT)
Quality Assurance
Quality Systems
Quality Control
Quality Planning
Regulatory Compliance
Change Control
Culture Change
FDA Readiness and Remediation
Recall / Field Action
Complaint Handling
Internal, Supplier, Third Party Audits
Inspection and Testing
Process Control
Control of Nonconforming Product
Corrective Action (CA)
Preventive Action (PA)
Company Details
- Employees
- 1
- Founded
- -
- Address
- Chapel Hill, Nc, Us
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Keywords
- Chapel Hill.
- HQ
- Chapel Hill, NC
- Competitors
- Priovant Therapeutics, Cedars-Sinai, Smith+Nephew, CREO.
Practical Compliance Results, Llc Questions
Practical Compliance Results, Llc's website is http://www.practicalcomplianceresults.com
Practical Compliance Results, Llc's LinkedIn profile is https://www.linkedin.com/company/practicalcomplianceresults
Practical Compliance Results, Llc has
1 employees.
View email and phone details for 1
employees at Practical Compliance Results, Llc.
Practical Compliance Results, Llc's industry is
Business Consulting and Services
Practical Compliance Results, Llc's top competitors are
Priovant Therapeutics,
Cedars-Sinai,
Smith+nephew,
Creo.
Practical Compliance Results, Llc's categories are Business Consulting and Services
Practical Compliance Results, Llc's founding year is 2019
