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:
Who Will Benefit:
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.
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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