Brief Understanding about procedures and Citations By USFDA

Name: Brief Understanding about procedures and Citations By USFDA
Rating: 4.1 (8 reviews)

Know about FDA terms, actions, how to comment on draft guideline and information on quality management maturity

Created byHitendrakumar Shah

Last updated 2/2024

English

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

Course content

1 section • 5 lectures • 3h 44m total length

Introduction - Training strategy in pharmaceuticals9:38
Learn to develop an effective pharmaceutical training strategy that meets cGMP and 21 CFR part 820 requirements, addressing training needs, records, and on-the-job and induction programs.
Form 483 and warning letter - understanding FDA procedure56:03
Learn how FDA form 483 observations lead to warning letters, and how to respond with prompt corrective action, CAPA, and documentation aligned with FDA SOPs.
Quality Management Maturity Program56:03
Understand FDA procedures for warning letters and Form 483 during inspections, including CAPA, closing meetings, prompt corrective actions, and the 15 working day response timeline.
How to submit comments on draft guidelines40:05
Learn how to submit comments on FDA draft guidelines, including level one and level two distinctions, online via regulations.gov or by mail, with docket numbers, timelines, formatting, and supporting documents.
21 CFR Part 210,211 and eCFR1:02:35
Understand 21 CFR parts 210 and 211 and eCFR to grasp cGMP essentials. See how training, doer and checker, and facility controls prevent observations and ensure compliant drug manufacturing.

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 Frame

The 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.

Who this course is for:

Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.