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Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance.

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Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

ComplianceOnline

Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug product in each country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping. These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training.

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Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung