ComplianceOnline

Small GMP problems which cause the biggest enforcement headaches: how to tackle them

Instructor: Steven S Kuwahara
Product ID: 700950
  • Duration: 75 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2008

Training CD / USB Drive

$500.00
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(For multiple locations contact Customer Care)
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Read Frequently Asked Questions

The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions.

Description

As an example, we will discuss the process for accepting raw material.

There are a number of GMP issues that are often considered to be minor issues or are difficult to detect if the inspector is inexperienced. Several of these issues have led to major GMP problems. The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material. Different companies follow various procedures, some of which are not acceptable and lead to major problems for the company.

Areas Covered in the seminar:

  • The need for periodic quality reviews within a company and of its suppliers.
  • Preventing bad habits.
  • Monitoring the warning letters.
  • Controlling raw material.
  • Environmental Control
  • Qualification processes.
  • Avoiding blind spots and minimizing critical requirements due to ignorance.

Who will benefit:

This presentation will be aimed at QA and QC personnel who must monitor company activities and prevent the development of "blind spots.".

  • Manufacturing and Regulatory personnel who must cooperate with Quality personnel.
  • Managers of different operational departments.
  • Project Managers.
  • Consultants.

Instructor Profile:

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. He has participated in the product development process for small molecule drugs and biologics, and has prepared or reviewed many CMC sections.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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