COURSE "AUDITING A VALIDATION PROGRAM - A RISK-BAS 2013 - Auditing a Validation Program - a Risk-Based Approach

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COURSE "AUDITING A VALIDATION PROGRAM - A RISK-BAS 2013 - Auditing a Validation Program - a Risk-Based Approach - Webinar By GlobalCompliancePanel

Website http://bit.ly/WXUkX5 | Edit Freely

Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

Deadline: March 07, 2013 | Date: March 07, 2013

Venue/Country: California, U.S.A

Updated: 2013-02-22 15:25:20 (GMT+9)

Call For Papers - CFP

Overview: A validation program must have three basic elements - policy/procedures, adequate training for execution and compliant/complete documentation. The audit should have a structure that includes a policy, plan, documentation of the audit activities and the reports and closure of any observations. There are critical processes and direct impact systems which should be the primary focus of our efforts. During an audit of a validation program, the focus should be placed on those critical processes or systems as they will affect our product quality in the most direct way. An audit of a validation program must also cover the validation status maintenance, specifically the change control program adequacy and documentation which will have a critical effect on our validation program compliance.

Why should you attend: The revised PV guideline is demanding that the industry focuses on the adequate design and qualification of facilities, systems, equipment and processes so an adequate validation program has to address these areas as well as the application of QbD designed processes.

Course Modules & Content Details:

Regulatory Background

Audit Requirements - Define Audit Scope and Plan, responsibilities and the audit process

Elements of a Validation Program to be audited:

Policy, Procedures and Handling of Deviations

Protocol Formats and Approval cycles

Training of Validation Personnel

Documentation of validation executions

Archiving/Filing/Access Control

Use and Control of external validation resources

Change Control - How it relates to the Validation Program?

Addressing Audit Observations and reports - prioritizing observations based on a risk-based analysis

Areas Covered in the Session:

Plan and organize for the audit

How to select the focus areas - primarily the critical processes and direct impact systems.

How to execute and document the audit results.

How to report the audit observations, the departmental response and the closure of the item.

Who Will Benefit:

Quality

Validation

Engineering

Top Management

Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology.

Price: $245.00

GlobalCompliancePanel

Phone: 800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://bit.ly/WXUkX5

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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