FDA Warnings : What Prompt FDA to Issue Letters & How to Avoid Them?
Master Framework of GxP/GMP Regulations, QMS, Quality Audit and How to Successfully Pass any Quality Audit!
Instructor :
Eleonora Babayants
Webinar ID:
2920
Date: NOV 27, 2024 (WED)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
What you will learn
- Framework of GxP/GMP regulations, QMS, and quality audit
- Commonly cited issues in FDA warning letters
- Risk areas that prompt FDA to issue these letters
- How to address issues & pass an audit
- How properly prepare for FDA inspections.
- What is quality management system
- Framework of GxP/GMP regulations, QMS, and quality audit
- Commonly cited issues in FDA warning letters
- Risk areas that prompt FDA to issue these letters
- How to address issues & pass an audit
- Different types of quality audits
- How properly prepare for FDA inspections.
Course Description
GxP/GMP regulations describe the required Quality Management System (QMS) for producing and testing products in the regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.
Regulated industries, such as food, pharmaceutical, medical devices, and cosmetics, must use GxP/GMP regulations.
A quality management system (QMS) ensures that a product is safe and meets its intended use. QMS has 4 main components:
- Quality Planning
- Quality Assurance
- Quality Control
- Quality Improvement.
Quality audit is the systematic inspection of QMS, which is carried out by an internal or external auditor or an audit team. It is an integral part of the organization’s QMS and central to GxP/GMP regulations.
FDA often inspects organizations in regulated industries, and if they find a deficiency, they will issue a citation or a warning letter.
In this interactive webinar, we will cover:
- The framework of GxP/GMP regulations, QMS, and quality audits.
- The most commonly cited issues in FDA warning letters.
- We will look at common trends in these letters and highlight risk areas that prompt the FDA to issue these letters.
- Finally, we will address how to address issues and adequately prepare for FDA inspections.
Join us now!
GxP/GMP regulations describe the required Quality Management System (QMS) for producing and testing products in the regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.
Regulated industries, such as food, pharmaceutical, medical devices, and cosmetics, must use GxP/GMP regulations.
A quality management system (QMS) ensures that a product is safe and meets its intended use. QMS has 4 main components:
- Quality Planning
- Quality Assurance
- Quality Control
- Quality Improvement.
Quality audit is the systematic inspection of QMS, which is carried out by an internal or external auditor or an audit team. It is an integral part of the organization’s QMS and central to GxP/GMP regulations.
FDA often inspects organizations in regulated industries, and if they find a deficiency, they will issue a citation or a warning letter.
In this interactive webinar, we will cover:
- The framework of GxP/GMP regulations, QMS, and quality audits.
- The most commonly cited issues in FDA warning letters.
- We will look at common trends in these letters and highlight risk areas that prompt the FDA to issue these letters.
- Finally, we will address how to address issues and adequately prepare for FDA inspections.
Join us now!
Why you should attend
GxP/GMP is about Quality Management System (QMS), where an organization needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements.
There are a few types of quality audits. One of them is the GMP audit. GMP audit is significant and critical for an organization in a regulated industry. The preparations for the audit should be done correctly before the audit.
The primary objective of the audit is to demonstrate compliance with GxP/GMP regulations. FDA can drop in anytime to perform an unannounced GMP audit or investigation.
A GMP audit is conducted to check whether your organization complies with GxP/GMP and identify if you have complete control over your processes, facility, and quality management system (QMS).
Join us in this webinar to learn about:
- What is a quality management system? Are you ready for the audit?
- Learn about GxP/GMP regulations and how they affect the quality management system and quality audit.
- In addition, learn about the most commonly cited issues in FDA warning letters and risk areas that prompt FDA to issue these citations and warning letters.
- Learn about different types of quality audits
- How to properly prepare for them,
- What actions do you need to take to ensure that your organization will pass an audit.
GxP/GMP is about Quality Management System (QMS), where an organization needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements.
There are a few types of quality audits. One of them is the GMP audit. GMP audit is significant and critical for an organization in a regulated industry. The preparations for the audit should be done correctly before the audit.
The primary objective of the audit is to demonstrate compliance with GxP/GMP regulations. FDA can drop in anytime to perform an unannounced GMP audit or investigation.
A GMP audit is conducted to check whether your organization complies with GxP/GMP and identify if you have complete control over your processes, facility, and quality management system (QMS).
Join us in this webinar to learn about:
- What is a quality management system? Are you ready for the audit?
- Learn about GxP/GMP regulations and how they affect the quality management system and quality audit.
- In addition, learn about the most commonly cited issues in FDA warning letters and risk areas that prompt FDA to issue these citations and warning letters.
- Learn about different types of quality audits
- How to properly prepare for them,
- What actions do you need to take to ensure that your organization will pass an audit.
Areas Covered
- GxP/GMP Framework
- Quality Management System (QMS)
- FDA Citations and Warnings
- Common Trends in FDA Warning Letters and Highlight Risk Areas
- Different Types of Quality Audits & How to Prepare for Them
- Actions You Need to Take to Pass An Audit
- GxP/GMP Framework
- Quality Management System (QMS)
- FDA Citations and Warnings
- Common Trends in FDA Warning Letters and Highlight Risk Areas
- Different Types of Quality Audits & How to Prepare for Them
- Actions You Need to Take to Pass An Audit
Who is this course for
- Quality Assurance
- Documentation Managers
- Records Managers
- Document Control
- Compliance
- Medical Affairs
- Regulatory Affairs
- IT
- Quality Assurance
- Documentation Managers
- Records Managers
- Document Control
- Compliance
- Medical Affairs
- Regulatory Affairs
- IT
Instructor Profile
Galaxy Consulting Founder and President Eleonora Babayants has many years of GxP/GMP hands-on experience in regulated industries. She worked with quality assurance and compliance officers to develop and execute compliance strategies and programs. She participated in the implementation of compliance requirements.
Her many years’ experience includes regulatory compliance, internal and external auditing, change management, documentation and records management, document control, electronic document management systems, information governance, IT systems management and validation.
Eleonora’s past work includes development and implementation of regulatory compliance policies, processes, and procedures, leading implementation and administration of document control and document management systems in full compliance with regulatory requirements, designing and implementing electronic documents workflows, leading enterprise content management initiatives, enabling enterprise search, improving systems information architecture, creating and implementing users’ training programs.
Eleonora ensured document management systems compliance with regulatory requirements. She collaborated with users to develop positive and productive approaches to regulatory compliance, coordinated, prepared, and participated in internal and external audits including FDA audits.
Eleonora’s experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.
