Webinar: Auditing cGMPs 101 The Basics

Auditing cGMPs 101 The Basics
Date: Every 2nd Friday
Time: 1:00 PM EST | 10:00 AM PST
Duration: 90 Min + Q&A
Price: $375.00

Webinar Description
This webinar explains how to Audit against cGMPs to significantly reduce costs and advoid FDA 483s. Learn exactly what is needed to be GMP Audit compliant in all three compliance areas: Manufacturing, Quality Assurance and Quality Control.
All attendees will receive:
  • Course presentation
  • Certification of Attendance from GXP Conferences


Webinar Objectives
  • Understand Auditing Concepts. From the Auditor's perspective.
  • Preparing for the Audit
  • Checklists and Audit Plans
  • The basic requirements
  • Standard Operating Procedures and other control documentation
  • Quality Assurance Preparation
  • Documentation Basics
  • HR Basics and Training Requirements
  • IT, MIS and computer Systems (including Part 11/Annex 11)
  • Validation Requirements
  • Manufacturing Requirements - In accordance with 21 CFR Parts 210/211
  • Site Preparation
  • Audit Wrap-up
  • Remediation and Resolution Concepts and Techniques
  • follow up
  • Q&A
Who Should Attend
  • Quality Assurance
  • Quality Control
  • Laboratory Staff
  • Managers
  • GMP, GCP, GLP Professionals
  • Information Technology
  • Regulatory Affairs
  • Trainers

Please forward to collegues and appropriate departments.

GxP Conferences and eLearning
PO Box 335
Medford, NJ 08055
t. (609) 859-3455
f. (856) 810-7339

Click on a date to register for this webinar:
03-4-2013 button_indiverg
03-18-2013 button_indiverg
04-8-2013 button_indiverg

   Instructor Profile
John Cuspilich
John has enjoyed over 26 years of hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries world wide.

Serving within various business units within Quality Assurance / Regulatory Affairs, Training and Development, Manufacturing, Research, Engineering, Technical Mechanical Departments, etc.., John has assisted many companies in meeting and exceeding regulatory compliance, pertaining to ‘for-cause’ issues or ‘due-diligence’ initiatives.

Assisting companies to achieve, resolve, remediate and exceed regulated industry requirements, mandates, ‘for-cause’ and ‘due-diligence’ priorities with the technique of promoting GxP standards and practices through interactive hands-on training.

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About GxP Conferences
GxP Compliances is an emerging leader in pre-market and post-market conformity and compliance online webinars tailored to meet the needs of those in a wide variety of regulated industries. Utilizing our innovative, technologically-advanced tools individuals have exclusive access to exceptional cutting-edge live series and individual training modules providing in-depth information related to conformity and compliance. Our unique online conferences have been created with the utmost in quality, with compliance and conformity in the forefront of all of our presentations.
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1:00PM EST - 10AM PST