Know about FDA terms, actions, how to comment on draft guideline and information on quality management maturity
What you'll learn
You need to know the FDA terms, procedures and expectations
When different forms are issued and what are the actions are expected
How you can ready for audit for computerised systems as per FDA expectations
How you can improve quality systems in quality maturity and how you can comment on draft guidelines
Requirements
The person should be full focussed during the session.
Description
This training video will provide insight on 1. Some examples of FDA warning letters about training 2. Why training is important? This will be explained with a small example. 3. The regulatory expectations from the training - EU, USFDA, and WHO 4. How to comply with these all expectations and many more.The next lecture will help you to understand many topics related to FDA Form 483 and Warning Letter - Understanding FDA Procedure. Below points are discussed during this session - Possible Regulatory or Enforcement Pathways What is a Form FDA 483? What should I do during the closing discussion and Form FDA 483 review? Post FDA 483 – How to Respond? What Should Your Response Include? Understanding of warning letter. Issuing Warning Letters - Factors to Consider by FDA Purpose of issuing a warning letter Ongoing or Promised Corrective Actions Response Letter Verification of Corrective Actions Multiple Centre Review Warning Letters Response – Time FrameThe other lecture with help you with how to submit comments on DRAFT FDA Guidelines. The content of the session is below; Introduction and overview of the topic.Types of Guideline Documents How to Submit Comments? Suggestions for Commenting Submitting comments on CDRH Guidelines Recommended format by CDRH References Q&A AND Vote of Thanks. The last lecture is based on the white paper issued by the FDA. FDA's Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. CDER is developing its QMM Assessment Tool (protocol and rubric) to evaluate how effectively establishments monitor and manage quality and quality systems. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.
Overview
Section 1: Introduction
Lecture 1 Introduction - Training strategy in pharmaceuticals
Lecture 2 Form 483 and warning letter - understanding FDA procedure
Lecture 3 Quality Management Maturity Program
Lecture 4 How to submit comments on draft guidelines
Lecture 5 21 CFR Part 210,211 and eCFR
Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.
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