Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on December 07 for a discussion of the webinar

webinar GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. These regulations describe required quality management system (QMS) for 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.

Quality management system (QMS)ensures that a product is safe and meets its intended use. QMShas four main components: qualityplanning, quality assurance,quality control,andquality improvement.

Quality auditis the process of systematic inspection of QMS which iscarried out by an internal or external auditor or an audit team. It is an important part of organization'sQMSand is the 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 describethe most commonly cited issues in FDA warning letters. We will look at common trends in these letters and will highlight risk areas that that promptFDA 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 product that meets customer and applicable statutory and regulatory requirements.There are few types of quality audits. One of them is 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 the 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 quality management system? Are you ready for the audit?

Learn about GxP/GMP regulations and how they affect quality management system and quality audit. 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 and how to properly prepare for them, what actions you need to take to ensure that your organization will pass an audit.

Key Learning

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical

devices, and cosmetics. These regulations describe required quality management system (QMS) for 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.

Quality management system (QMS)ensures that a product is safe and meets its intended use. QMShas four

main components: qualityplanning, quality assurance,quality control,andquality improvement.

Quality auditis the process of systematic inspection of QMS which iscarried out by an internal or external

auditor or an audit team. It is an important part of organization'sQMSand is the 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 describethe most commonly cited issues in FDA warning letters. We will look at common trends

in these letters and will highlight risk areas that that promptFDA to issue these letters. We will address how

to address issues and properly prepare for FDA inspections.

Webinar Takeaways

  • GxP/GMP Framework
  • Quality Management System
  • FDA citations and warnings
  • Quality Audit

Who Will Benefit

  • Quality Assurance
  • Documentation Managers
  • Records Managers
  • Document Control
  • Compliance
  • Medical Affairs
  • Regulatory Affairs
  • IT

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


Faculty Eleonora Babayants

Faculty Eleonora Babayants

Galaxy Consulting Founder and President. She worked with quality assurance and compliance officers to develop and execute compliance has many years of GxP/GMP hands-on experience in regulated industries. 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.

Choose a Purchase Options

$199

Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email


$399

Group Up to 5 Participants

You get 5 log-in for the live 90-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email


$289

Recorded Access Single - 6 month Access

You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session


$389

Training DVD

Within 48 hours delivered - Lifetime Access ,Audio recording of a webinar and reference manual delivered by download. Listen anytime on any compatible device.


$399

Live + Recorded Access

You get one log-in for the live & recorded 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email