Production and Process Controls - Ensuring your medical device conforms to its specifications

Why Should You Attend:

This presentation will help you get an in-depth understanding of what regulatory agencies such as the FDA are requiring for production and process controls as they relate to documentation, change control, environment control, personnel, contamination control, buildings, equipment, manufacturing material and automated processes. The topics and pointers within the presentation will provide the tools necessary to evaluate your already-existing processes to determine if it meets requirements and if your systems are robust enough to ensure actions are effective or overly-complicated and preventing smooth operation. We’ll provide an overview of commonly-used tools, help understand some misconceptions with implementation, and provide tips and tricks for ensuring your device conforms to its specifications.

Areas Covered in the Webinar:

• Regulatory requirements for production and process controls
• Responsibilities of manufacturers
• Best practices for implementation
• FDA expectations
• Documentation requirements

Who Will Benefit:

• Quality assurance professionals – associates, engineers, and managers
• Regulatory professionals

Denise Wrestler
QA and RA Consultant , CYA Medical Device Consulting LLC

With over 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) as well as lead auditor certification for ISO 13485. 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.

CYA Medical Device Consulting provides services to individual clients as well as companies ranging from 10 to 1,000 employees.

Topic Background:

All medical device manufacturers are required to have a robust system in place to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications. Many manufacturers are overwhelmed with the requirements of 21 CFR Part 820.7 and are unsure how to comply with these regulations. Other manufacturers may have documented procedures and systems in place to meet the requirements of this section but are unsure if it’s appropriate (i.e. too complex or too broad) or effective.

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