Quality school training courses in Brunswick, ME (public, in-house or online)

The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolve during pre-market operations, what its function is when a drug is marketed and how opportunities for product improvement should be identified and implemented throughout the product life cycle. The main element discussed in Q10 is what management, especially senior management, should be responsible for in ass...

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Government regulations have both explicit and implicit requirements for an internal audit function in the pharmaceutical and related industries. Auditing is a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance. The course will deal primarily with auditing techniques which are applicable to any industry or function. Specific examples will cover auditing of certain aspects of operations for compliance with GMP, GCP and GLP...

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The FDA is using a systems approach for both its domestic and foreign drug cGMP inspections. The approach consists of classifying a firm¡¯s operations into six types of systems: (1) The Quality System (2) Facilities & Equipment System (3) Materials System (4) Production System (5) Packaging & Labeling System and (6) Laboratory Control System. The systems inspected depend upon the purpose of the inspection and the FDA¡¯s prior experience with the firm but always includes the Quality System for whic...

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The ExpertRating Total Quality Management Course (leading to Total Quality Management Certification) is a well researched 100 page online course that has been developed for people who would like to master the science of Total Quality Management. The course has been designed so that it is easily understood by beginners and people new to TQM, apart from seasoned project managers.

The TQM Training course includes all the TQM tools, TQM techniques and TQM concepts apart from TQM Implementati...

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Benefits
Turn around your ERM program; make it directly relevant to corporate goals

Make risk assessment credible as basis for corporate decision-making

Substantiate your planning and budget proposals

Instil confidence among stakeholders by showing your risk process has rigor

Show due diligence and support good governance

Understand where and how financial models fit into the picture

Facilitate solutions in complex and controversial multi-stakeholder ...

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