Webinar on Development and Implementation of an External Auditing Program as part of a Pharmaceutical Manufacturing Quality System

MessageThis Webinar is over
Date Nov 18, 2015
Time 10:00 am
Cost $150.00
The presentation will explain the need and implementation of a pharmaceutical manufacturing external auditing program as part of an overall GMP compliant Quality System. The auditing process plays a critical part in providing a safe and effective product from a practical business, regulatory compliance and most importantly the patient perspective.
Evaluation of suppliers and contractors is key to a successful Supplier/Vendor qualification process as well as in obtaining and maintaining regulatory approval. Though there are other aspects of the qualification process such as establishing a supply or manufacturing agreement, a quality or technical agreement and performing trial testing or manufacture, the performance of an audit allows for onsite real time assessment. 

Why should you Attend: 

The use of chemical and material suppliers, contract manufacturers and contract testing lab is integral in today’s pharmaceutical manufacture. With ever increasing diversity of WW suppliers and complexity in the regulatory and scientific realm of pharma manufacture the quality and control of materials and services in a cost effective manner is of paramount importance. The establishment of risk based a robust external auditing program is necessary as part of the qualification process of any vendor or contract organization. 

The presentation will allow you to understand the why and how of developing and implementing such a program to allow control and confidence,
  • For the approval of your product
  • In the manufacture, control or testing of your product at contract service organizations
  • In receiving materials for your pharma process or product with the assurance that they conform to both yours and regulatory requirements
Areas Covered in the Session:
  • Why perform audits?
  • Regulatory basis for external audits
  • Auditing as part of qualification
  • Steps of the auditing process: SOP
  • Types of auditees
  • Types of audits
  • Behavior, communication and follow-up
Who Will Benefit:
  • Quality Assurance Director, Manager and Supervisor
  • Quality Assurance Specialists
  • Production/Operations Director, Manager and Supervisor
  • Quality Control Director, Manager and Supervisor
  • Purchasing Director, Manager
  • Supply Chain Directors , Manager
Speaker Profile:
Joseph Habarta Ph.D. is founder and principal of J. Habarta Consulting that provides specialized consulting and assistance in the areas of international GMP and quality for the biotechnology and pharma industries. Dr. Habarta brings over 35 years of experience in these industries and has been a senior quality executive in both large pharma and start-up biotech organizations. His accomplishments range from numerous successful international PAI inspections to the establishment and advancement of cGMP quality organizations in many companies.

Contact Detail:

NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216, 
Fremont, CA 94539, USA. 
Phone: +1-800-447-9407 
Email: support@compliance4All.com
Event Link :  http://bit.ly/1OFoeuk


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