Cerified Quality Associates
Our services are customized to fit your needs. If you are looking to implement ISO 9001 or ISO 13485, we can conduct a gap assessment, prepare an implementation plan or provide a turn-key QMS tailored to fit your needs. Certified Quality Associates’ auditors can perform your internal and external audits as well as qualify your own auditors. Our consultants have technical, operational and strategic expertise in the medical device and pharmaceutical industries.
Certified Quality Associates has the qualified resources to support:
- United States: 21 CFR Parts 7, 11, 21, 210, 211, 803, 806, 812, 820
- Canada: CFDA Division C.02, CMDR SOR/98-282
- EU: MDD 93/42/EEC
- Global: ICH Q7, ICH Q10, ISO 9001, ISO 13485, ISO 19011
- - Quality System Implementation
- - Policies and Procedure Writing
- - Post Market Surveillance
- - Trending
- - Internal Auditing
- - Supplier Qualification
- - Compliance Strategies
- - Regulatory Submissions
- - Regulatory Correspondence
- - Pre-Submission Meetings
- - Risk Assessments
- - Technical File/ERC Development
- - Internal Auditor Qualification Programs
- - ASQ Certification Preparation Courses
- - RAC Exam Preparation Courses
- - Utilizing Quality Tools
- - Data Mining and Analysis
- - Scoping Problems
- - Investigating Root Causes
- - Planning Implementation
- - Validating Corrective Actions
- - Verifying Effectiveness
Our staff of certified industry professionals and former FDA employees have the knowledge and experience to anticipate your needs and respond effectively.
Auditing
Our certified auditors can save you time and money. In addition to helping you complete your internal audit schedule on time, we can conduct third party audit to ensure that your suppliers, contract manufacturers, drug depots, warehouses and contract laboratories are qualified and compliant.
483s and Warning Letter Responses
Our staff includes former FDA Compliance Office staff who can provide an insider’s perspective on your FDA 483 or a Warning Letter. We can also help you write a thorough, complete response that avoids common mistakes, such as lack of objective evidence, over-committing and misinterpretation.
CAPA Coaching
Inadequate corrective and preventive action investigations was the most frequently cited inspectional observation issued to medical device firms by FDA investigators in 2015. Whether your company is new to CAPA or you need help with a specific problem, our experts can help. Contact us today.
This company provides regulatory, compliance and quality mangement system consulting to medical device and pharmaceutical manufacturers. We are nor affiliated with any government agency or the American Society for Quality (ASQ).