Webinar Search Results : 5 Upcoming webinars found.
Jeff Kasoff Friday, January 25, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
Complaint Handling in Compliance with FDA and ISO Regulations
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

Jeff Kasoff Friday, February 8, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.

Jeff Kasoff Friday, February 22, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
Equipment Validation, Tracking, Calibration and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements.

Jeff Kasoff Friday, March 8, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
The FDA Inspection: Preparation, Management, and Follow - up
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics..

Jeff Kasoff Friday, March 22, 2019
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Jeff Kasoff
FDA Inspections - Do's and Don'ts
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

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