RAPS pre-approved webinar on

Policy/procedures, adequate training for execution and compliant/complete documentation are the three basic elements of a validation program.

Fremont, CA (prHWY.com) February 26, 2013 - Summary: "Auditing a Validation Program -a Risk-Based Approach" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on March 7. The speaker at this session is Miguel Montalvo, President of Expert Validation Consulting. This webinar will be of 90 minutes' duration and earns up to 1.50 RAC credits towards a participant's RAC recertification upon full completion.
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Description:
Policy/procedures, adequate training for execution and compliant/complete documentation are the three basic elements of a validation program. The audit's structure should include a policy, plan, documentation of the audit activities and the reports and closure of any observations.
In addition, there are critical processes and direct impact systems which should be the primary focus of PV efforts. During an audit of a validation program, the focus should be placed on those critical processes or systems as they will affect product quality in a very 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 validation program compliance.

The recent revision in the PV guideline demands that the industry focus on the adequate design and qualification of facilities, systems, equipment and processes, because an adequate validation program has to address these areas as well as the application of QbD designed processes. This session will give a detailed explanation of all these.

The expert will cover the following areas during this webinar:
o Plan and organize for the audit
o How to select the focus areas - primarily the critical processes and direct impact systems
o How to execute and document the audit results
o How to report the audit observations, the departmental response and the closure of the item.
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When: March 7, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Miguel Montalvo, who has a B.S. in Chemical Engineering and an MBA, is President, Expert Validation Consulting. He has over 28 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 and medical device industries.
He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics. He is a member of the Journal of Validation Technology editorial board and of the PDA Annual Program Committee for their Annual meetings.
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For whom:
This webinar will benefit professionals in
o Quality
o Validation
o Engineering
o Top Management
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Duration: 90 minutes
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To enroll for this webinar, contact
Phone: 800-447-9407

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Tag Words: complaince training, regulatory compliance, fda training, medical device training, pharmaceutical compliance, pharmaceutical training

Categories: Health

Press Release Contact
USA
GlobalCompliancePanel,
Livermore Common, Fremont,
CA 94539, USA Phone: 1800 425 9407

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