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.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

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.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

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.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

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?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

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?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare

Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details

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?

Speaker: Jeff Kasoff | View Anytime | Duration: 60 Minutes | Price: $199.00 | View Details