DESCRIPTION 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 […]

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DESCRIPTION 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 […]

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DESCRIPTION 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 […]

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DESCRIPTION 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 […]

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How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation   Register Now!     Description: Areas Covered in the seminar Documents Used by FDA Inspectors Operations Manual (IOM) CAPA Implications, by Section Requirements Recommended Methods of Compliance for Each Requirement CPG Manual 7382.845 CAPA Implications, by Section Requirements Recommended Methods of […]

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Complaint Handling in Compliance with FDA and ISO Regulations – 1,5 hours webinar Register Now! 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 […]

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WEBINAR TRAINING – TRADITIONAL 510 K – FDA REGISTRATION – REGULATORY (Buy Ticket Now) Download the course Brochure Availability: Right Now (Recorded Presentation) Duration: 30 min. (the average time to complete the training program). Description: This webinar course will describe how to manage a new Traditional 510k, providing description of the details to include in each Section […]

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FDA REGISTRATION: MEDICAL DEVICES, IVD, COMBINATION PRODUCTS (Buy Ticket Now)  Download the Course Brochure Availability: Right Now (Interactive Presentation) Duration: 50 min. (the average time to complete the training program). Description: This Webinar course will introduce you to the FDA Regulation for Medical Device, IVD and Combinations products: Device Classification Class I Medical Device Class […]

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DESIGN CONTROL 21 CFR 820.30 – INTERACTIVE PRESENTATION TRAINING (Buy Ticket Now) Download the Course Brochure Availability: Right Now (Interactive Presentation) Duration: 70 min. (the average time to complete the training program). Description: This webinar course will introduce you to the activities that are required by FDA Design Control according to 21 CFR 820.30. Design Controls – Why? Design Controls […]

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