Purchase the Pharmaceutical Supplier, Contractor and GMP Audit Lifecycle Guide titled "Supplier Auditing and Good Manufacturing Practices Supplier/Contractor Audit Lifecycle COMBO" for $546.00 from IndustryMatter.com. 

This combination of 2 webseminars in CD format covers Good Manufacturing Practice (GMP) Audits of pharmaceutical and drug manufacturing, suppliers, contractors and subcontractors. Biopharmaceutical and pharmaceutical company managers and executives who purchase these reference guides will improve quality, decrease expenses and improve their ability to document operational and compliance risks by creating an audit plan definition and managing the full audit lifecycle.

Effective audit management drives continuous improvement by ensuring that established quality requirements for products and processes are being met. For all Bio/Pharmaceutical which are regulated by the FDA, FAA or are following quality standards such as ISO 9000/13485/14000, regular audits are also essential to reduce the risk of noncompliance. The efficiency of audit execution and integration of the audit process with the overall enterprise-wide quality management system are critical for successful audit management.

This webseminar prepares individuals to act in the role of Supplier Quality Auditor. You will learn the necessities to become effective auditors, developing the knowledge and skill sets to accomplish tasks relating to pertinent regulatory requirements.

Learn how to:

There continues to be an increase in the use of specialty manufacturers and contractors in the development and manufacture of pharmaceuticals and medical devices. Along with this increase, there has been increased emphasis on the control of outsourcing as expressed in the FDA's Quality Systems Approach to the GMPs as well the International Conference on Harmonization Q8 & Q10 guidance documents. The Quality Systems Regulation for devices discusses these controls in SubPart E, Purchasing Controls.

This presentation uses graphics to explain this lifecycle beginning with the decision to purchase or outsource and ending with maintaining continued qualification. Some points of discussion include: