ComplianceOnline

GMP auditor training for pharmaceutical companies

Instructor: James Harris(PhD)
Product ID: 701627
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$349.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$600.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

In this GMP auditor training for pharmaceutical companies you will learn what a GMP auditor should do and how to conduct an audit. An overview of various GMP regulations and discussion on most commonly cited GMP violations and how to find and correct it.

Why Should You Attend:
Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regulations before an FDA audit occurs. There are several problems with this approach, however. The auditors may not fully understand the regulations and may not have been trained in audit techniques. Another impediment is that an internal auditor is monitoring his/her friends. It is very difficult to point out errors committed by a friend since by calling attention to a lack of compliance may be interpreted as "telling on" the friend and possibly causing a problem for them.

This program will cover two major topics. First, we will discuss auditing. This portion will show what an auditor does and how an audit is conducted. We will also stress the difficulties faced by an auditor who is from within the organization being audited.

The second portion of this program will present an overview of the various GMP regulations that a manufacturer must work within. Lastly, we will identify the most commonly cited GMP violations and show how they are found and identified. Topics included in this presentation include:

  • Audit goals
  • Audit techniques
  • Time requirement for a full audit
  • Origin of GMP regulations
  • GMPs to be monitored during an internal audit
  • Most common FDA citations for non-compliance
Areas Covered in the Seminar:
  • Why audits are conducted.
  • How to conduct an audit.
  • What to look for.
  • Common citations in facilities.
  • Common citations for documentation.
  • Auditing of records.
  • Organizational citations.
  • Laboratory audits.
  • Validation.

Who Will Benefit:
  • Supervisors
  • Managers
  • Directors
  • VPs of manufacturing or Quality

Instructor Profile:
James R. Harris, Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. One of the services that were highly sought by clients was assistance in conducting clinical trials. He has assisted many firms in designing the trials, writing trial protocols, selecting a CRO to perform the project management, and oversee the trial process.

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