THIS GUIDANCE DOCUMENT CONTAINS SEVERAL STATEMENTS 2013 - Statistical Procedures Needed for Compliance with the Guidance on Process Validation - Webinar by GlobalCompliancePanel

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Category Webinar, Health, Medical, Pharma, Clinical

Deadline: August 22, 2013 | Date: August 22, 2013

Venue/Country: USA, U.S.A

Updated: 2013-07-23 18:07:31 (GMT+9)

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This guidance document contains several statements that make it clear that statistical procedures will be expected. Some of these procedures are of an advanced nature and companies need to be prepared to meet these requirements.

Areas Covered in the Session:

In general what topics does the new draft guidance cover?

What are the specific statements?

What are these statistical procedures, and how are we expected to apply them?

If we lack statistical expertise, what can we do to ensure compliance?

Who Will Benefit:

Personnel who will need to plan and execute process validation studies.

Supervisors who will need to review process validation reports and execute studies.

Quality assurance and control personnel.

Managers responsible for quality operations.

Auditors and others who will need to periodically review or check studies.

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 .

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