This webinar will define what each of these terms mean as defined within the FDA 21 CFR Part 820, including "human translations" to these often hard-to-read regulations.
We will cover what documentation is typically included with each category of records, and what FDA auditors will generally ask for during their inspection.
We will discuss methods for ensuring your firm has included all records needed to show compliance to regulations and clarify any terms that may be unfamiliar when compiling your DMR, DHR, and DHF.
At the end of the presentation, the speaker will answer any questions the audience may have.
Why should you Attend
Are you unfamiliar with the term "quality record"? Are you sure your company is meeting the requirements for quality records?
What are the main differences in the types of records needed to show compliance to regulation?
Like many who are new to the multitude of acronyms that make up the requirements of the FDA, terms like "DMR", "DHR" and "DHF" can be confusing.
Areas Covered in the Session
- Device Master Records (DMR)
- Device History Records (DHR)
- Design History File (DHF)
- Records required to show evidence of compliance to 21 CFR Part 820
Who Will Benefit
- Executive Management
- Quality Assurance Professionals
Denise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA's "least burdensome approach" and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.
Denise Wrestler holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. Additionally, Ms. Wrestler holds ASQ Certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA). A contributing author to ASQ's monthly publication Quality Progress magazine, Ms. Wrestler remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Wrestler has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation.