Hot topic

Quality Risk Management:

Applying the principles and tools

In the past six months, we’ve all witnessed how risks are expressed, evaluated, and treated.

The Eyjafjallajökull volcano and the catastrophic oil spill in the Gulf of Mexico have shown different consequences of risk management.

Risks are a part of any endeavor. In our two-day workshop we will examine ways to proactively assess, evaluate, treat, and monitor risks and look at how this can support quality pharmaceutical and biopharmaceutical products.

James L. Vesper, Copenhagen, September 9-10

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New book

Quality Systems Handbook

for Medical Device

Anna Lundén has gathered her experience from thousands of training hours in the Medical Device industry in this clear and easy to read book.

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The GMP Handbook

- quality systems for the
pharmaceutical industry

Anna Lundén has gathered her experience from thousands of GMP training hours in the pharmaceutical industry in this clear and easy to read book. More »

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Best Practices for Global Investigational Medicinal Product (IMP) Management

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Cleaning Validation - Strategy, techniques and regulations

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Compliance for Biopharmaceutical API Process Validation

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Contamination control in cleanrooms - GMP requirements and industrial practice (US and EU)

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Good Distribution Practice - A Practical Approach

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Good Engineering Practice (GEP) - A Practical Approach for Engineers

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GMP Compliance for Biopharmaceutical/Biologic APIs

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Design Control Requirements and Industry Practice

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GMP Compliance and Auditing for Sterile Pharmaceuticals

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GMP Compliance for Quality Control and Laboratory Operations

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Quality Risk Management: Applying the principles and tools

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Cleaning Validation - Strategy, techniques and regulations

»

Contamination control in cleanrooms - GMP requirements and industrial practice (US and EU)