DURATION:

1 h + 10 min. Question Time

COMPLAINT HANDLING IN COMPLIANCE WITH FDA AND ISO REGULATIONS

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Description:

Areas Covered in the seminar

·         FDA and ISO requirements for complaint handling

·         Establishment of complaint handling program

·         What constitutes a complaint

·         How to Handle “non-complaints”

·         The roles of investigation and corrective action in complaint handling

·         Complaint trending and reporting

·         Application of risk management to complaint handling program

·         Benefits/Detriments of a Reply to the Customer

LEVEL: INTERMEDIATE

Why You Should attend

Complaint handling is 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 complaint, and how to handle “non-complaint” feedback. Recommended best practices on how to include complaint trending into your firm’s CAPA program will be included. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.

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

Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.

Online Training Programs Includes:

• Answer to questions submitted during the webinar.
• An online final assessment with multiple choice questions.
• A Certificate of Completion.

Live Course Presented and Commented by:

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.