FDA Warnings - Common Trends and Observations and How to Prepare for FDA Inspection and Pass it Successfully Recorded Webinar | Eleonora Babayants | From: Dec 10, 2020 - To: Dec 31, 2020 |
GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. These regulations describe the required quality management system (QMS) for the production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.
A quality management system (QMS)ensures that a product is safe and meets its intended use. QMShas four main components: quality planning, quality assurance, quality control, and quality improvement.
Quality audit is the process of systematic inspection of QMS which is carried out by an internal or external auditor or an audit team. It is an important part of an organization's QMS and is a major part of 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 webinar, the framework of GxP/GMP regulations, QMS, and quality audit will be described.
We will also describe the most commonly cited issues in FDA warning letters. We will look at common trends in these letters and will highlight risk areas that prompt the FDA to issue these letters. We will address how to address issues and properly prepare for FDA inspections.
Why Should You 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 very important and critical for an organization in a regulated industry. The preparations for the audit should be done properly 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 to identify if you have full control over your processes, facility, and quality management system (QMS).
What is a quality management system? Are you ready for the audit?
Learn about GxP/GMP regulations and how they affect the quality management systems and quality audits. Learn about the most commonly cited issues in FDA warning letters and risk areas that prompt the FDA to issue these citations and warning letters.
Learn about different types of quality audits and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.
Who Will Benefit?
Industries Who Can Attend?
This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel
Eleonora Babayants is a Galaxy Consulting Founder and President, She is a documentation management professional and hands-on consultant with over 25 years of experience in documentation and records management, document control, regulatory compliance, internal and external auditing, electronic document management systems, information governance, and change management. Eleonora's past work includes development and implementation regulatory compliance processes and procedures, leading implementation and administration of document control systems in full compliance with regulatory requirements, enabling enterprise search, improving systems information architecture, creating and implementing users training programs.
She led electronic document management systems selection and deployment, administered and supported these systems, web information portals, knowledgebase applications, recommended and implemented re-structuring of the content and the information architecture of these systems. She worked very closely with IT to do feasibility assessment and to capture users’ requirements.
She wrote technical documents and created documents templates. Eleonora's experience spans multiple industries including biomedical, pharmaceutical, and medical devices companies.
