Complaint Management and Reportable Events: Compliant Practices that Satisfy Customer Satisfaction

Jeff Kasoff

Starting at

$999


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Duration: 9Hrs 30 Mins  (2 Hrs./Day)              

No of modules: 4 modules (1 Module/Day/Week)

Dates:  

1st May Chapter 1 @12PM EST

8th May Chapter 2 @12PM EST

15th May Chapter 3 @12PM EST

22nd May Chapter 4 @12PM EST

Mode of delivery: Online

CEU: 9

Overview:

Regulatory compliance is increasingly visible in healthcare compliance, clinical research compliance, and in all Life Science industries, including pharmaceutical, food, and medical device industries.

Plianced brings Master programs, which allow learners to attend live classes, complete assignments at their convenience.

 

ABOUT THE PROGRAM: 

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a the complaint, and recommended practice on how to handle "non-complaint" feedback. The application of risk management to a complaint handling system and a specific risk management system will be explained.

This master program contains a streamlined review of the regulations, allowing the majority of time to be spent on a detailed focus on critical process requirements for compliance with the regulations. Jeff will also call from his 30+ years of experience in this area to put forth recommendations for methods of documentation that is straightforward and compliant. Among these recommendations are contents of complaint records, root cause investigations, and corrective actions. This webinar also covers the application of risk management principles to a complaint investigation.

PROGRAM OBJECTIVES:

Many complaints include terminology that is unlikely to withstand an FDA or ISO audit, such as “isolated occurrence” and “low risk.” Further, from a business perspective, how do you let your customers know that you received their complaint when you know that their next question may be the dreaded “What did you find out?” A compliant quality system has, as one of its supports, a robust complaint system that is both compliant and business-savvy. This session will address these issues and more.

LEARNING METHODOLOGY:

Topic

Delivery mode

Presented By

Date

Time

Duration

Module 1:

Complaint Handling (Part 1)

Live class

Plianced Expert

1st May 2020

12.00 pm ET

2 hrs

Q&A Session

15 mins

Module 2:

Complaint Handling (Part 2)

Live class

Plianced Expert

8th May 2020

12.00 pm ET

2 hrs

Q&A Session

15 mins

Module 3:

Adverse Event Reporting

Live class

Plianced Expert

15th May 2020

12.00 pm ET

2 hrs

Q&A Session

15 mins

Module 4:

Recalls / Field Corrective Actions

Live class

Plianced Expert

22nd May 2020

12.00 pm ET

2 hrs

Q&A Session

 

 

 

 

15 mins

Online Assessment

Final assessment and certificate

Online test

Online Quiz

22nd May 2020

2.15pm

30 mins

 

 

DETAIL COURSE CONTENT:

 

Module 1:

Complaint Handling (Part 1)

-      Regulatory Overview: FDA, ISO 13485

-      Definitions

-      Application of Definitions

-      The Value of “Non-complaints”

-      Complaint Triage and Handling

-      Complaint Investigations

-      “Closing” Complaints

Module 2:

Complaint Handling (Part 2)

-      Contents of Complaint Form

-      Complaint Review and Trending

-      Implementation of Risk Management into Complaint Handling

-      Common Pitfalls, How to Overcome Them

-      Complaint or Non-complaint?

-      Benefits/Detriments of a Reply to the Customer

Module 3:

Adverse Event Reporting

-      Regulatory Overview: FDA, ISO 13485

-      MDRs: Reporting Process and Requirements

-      Vigilance Reports: Reporting Process and Requirements

Module 4:

Recalls / Field Corrective Actions

-      Regulatory Overview: FDA, ISO 13485

-      Recall/FCA Classifications

-      Corrections and Removals

-      Market Withdrawal and Stock Recovery

 

Online Assessment

 

 

Final assessment and CCU certificate

 

Who will benefit:

·         Customer Service (your “complaint taker”)

·         Regulatory personnel

·         Quality Engineering personnel

·         Sales and Marketing personnel

·         Customer Service personnel

·         R&D personnel

·         Manufacturing Engineering

·         Executive Management

·         Consultants

·         Quality system auditors

What will you get?

1)      Course Material/Slide deck

2)      Access to the recorded version of the entire 9 hours session

3)      Certificate of participation with Plianced CEU Credits

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Jeff Kasoff,

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.


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