Blogs and Articles

Regarding response to Complainant, What are you typically seeing “Thank you for your Complaint ” or “More specific to Complaint Handling”?

10/29/2020 06:01 AM

Webinar - Complaint Handling

Definition of Day zero or consideration of Day Zero in cases where the Company uses third party call center to perform intake of complaints from the open channel for a toll free number, fax, Web email

10/29/2020 05:42 AM

Definition of Day zero or consideration of Day Zero in cases where the Company uses third party call center to perform intake of complaints from the open channel for a toll free number, fax, Web email

Some regulatory inspectors interpret response as an action finding and not a simple acknowledgement of receipt. Are we seeing a trend in one direction?

10/29/2020 05:00 AM

Webinar - Complaint Handling - Best Practices Some regulatory inspectors interpret response as an action finding and not a simple acknowledgement of receipt. Are we seeing a trend in one direction?

We are a drug manufacturer, in your experience what is the percentage of companies whose response to the customer consists of a simple response to the customer versus a response which include a finding and a corrective action?

10/29/2020 04:54 AM

Complaint Handling - Best Practices

What is the standard for Due Diligence attempts to procure samples responses from unresponsive Complainant?

10/29/2020 04:29 AM

Complaint Handling - Best Practices

What is an ideal timeframe followed by the pharmaceutical industry to close Complaints when you are dealing with CMO(Contract Manufacturing Organization) or CPO.

2/7/2019 05:56 AM

Complaint Handling - Best Practices

What is the difference between FDA Investigator and FDA Inspectors?

3/22/2017 06:12 AM

Webinar - FDA Off-Label Promotion Guidelines

Blogs #Complaint Handling

Regarding response to Complainant, What are you typically seeing “Thank you for your Complaint ” or “More specific to Complaint Handling”?

Definition of Day zero or consideration of Day Zero in cases where the Company uses third party call center to perform intake of complaints from the open channel for a toll free number, fax, Web email

Some regulatory inspectors interpret response as an action finding and not a simple acknowledgement of receipt. Are we seeing a trend in one direction?

We are a drug manufacturer, in your experience what is the percentage of companies whose response to the customer consists of a simple response to the customer versus a response which include a finding and a corrective action?

What is the standard for Due Diligence attempts to procure samples responses from unresponsive Complainant?

What is an ideal timeframe followed by the pharmaceutical industry to close Complaints when you are dealing with CMO(Contract Manufacturing Organization) or CPO.

What is the difference between FDA Investigator and FDA Inspectors?