Outsourcing Management–Effective Contract Manufacturers, Supplier Evaluation, Approval

Feb. 12, 2013 - PRLog -- Of late, the FDA has raised the bar of its expectations for medical products of all types and specifications. This is particularly so after the Heparin case of 2008. Along with this isolated case; globalization has set in, meaning that more than four-fifths of the API’s in the US are from other countries.

This scenario calls for very strict enforcement and implementation of materials that come from outside. When American companies outsource their manufacturing processes; they need to make effective planning and risk assessments. They need abundant resources in dealing with outsourcing controls.

This webinar is a learning session on how to implement steps with which to ensure that controls are put in place. All these were quite loosely put in place; from now on, there is strict requirement on minute aspects, too.

This session will include a process for selection, evaluation, audit, approval and monitoring of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product.

This course will discuss the regulatory expectations and other industrial references/standards that will impact participants’ system. It will then move on to a discussion of the general requirements of a vendor/supplier (outsourcing management) control program. It will also explain the importance of the audits and the final contract/quality agreement.

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When: February 21, 10:00 AM PDT | 01:00 PM EDT

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By whom:

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 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:

o   Purchasing

o   Materials Management

o   Development

o   Quality

o   Manufacturing

o   Engineering

o   Top Management

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Duration: 90 minutes

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To enroll for this webinar, contact

webinars@globalcompliancepanel.com

Phone: 800-447-9407  

https://www.globalcompliancepanel.com/