Copenhagen, Denmark, September/October/December 2010

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Best Practices for Global Investigational Medicinal Product (IMP) Management  #5219

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Cleaning Validation - Strategy, techniques and regulations  #5220

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Compliance for Biopharmaceutical API Process Validation  #5213

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Contamination control in cleanrooms - GMP requirements and industrial practice (US and EU)  #5223

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Design Control Requirements and Industry Practice  #5307

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GMP Compliance and Auditing for Sterile Pharmaceuticals  #5303

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GMP Compliance for Biopharmaceutical/Biologic APIs  #5310

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GMP Compliance for Quality Control and Laboratory Operations  #5202

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Good Distribution Practice - A Practical Approach  #5222

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Good Engineering Practice - A Practical Approach for Engineers  #5224

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Quality Risk Management: Applying the principles and tools  #5221

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Cleaning Validation - Strategy, techniques and regulations  #5220

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Contamination control in cleanrooms - GMP requirements and industrial practice (US and EU)  #5223

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Auditing & Inspections

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GMP Compliance Auditing  #5201

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GMP Compliance and Auditing for Sterile Pharmaceuticals  #5303

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Handling foreign inspections in a multicultural environment  #5107

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Understand ICH Q8/Q9/Q10 in your GMP environment  #5106

Biopharmaceuticals & Biotechnology

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Compliance for Biopharmaceutical API Process Validation  #5213

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GMP Compliance for Biopharmaceutical/Biologic APIs  #5310

Cleaning & Cleaning validation

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Cleaning Validation - Strategy, techniques and regulations  #5220

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Contamination control in cleanrooms - GMP requirements and industrial practice (US and EU)  #5223

Clinical Trial Materials

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Best Practices for Global Investigational Medicinal Product (IMP) Management  #5219

GDP (Good Distribution Practice)

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Good Distribution Practice - A Practical Approach  #5222

GEP (Good Engineering Practice)

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Good Engineering Practice - A Practical Approach for Engineers  #5224

General GMP Compliance

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Batch Record Review and Investigations  #5301

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CGMP: Interpretation and Application  #5302

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GMP Compliance for Biopharmaceutical/Biologic APIs  #5310

Laboratory Operation

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GMP Compliance for Quality Control and Laboratory Operations  #5202

Medical Device

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Design Control Requirements and Industry Practice  #5307

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Process Validation Requirements and Industry Practice  #5309

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Quality System Requirements & Industry Practice  #5501

Risk Management

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Quality Risk Management: Applying the principles and tools  #5221

Sterile Pharmaceuticals

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GMP Compliance and Auditing for Sterile Pharmaceuticals  #5303

Validation

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Cleaning Validation - Strategy, techniques and regulations  #5220

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Compliance for Biopharmaceutical API Process Validation  #5213

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Validation and Qualification Compliance Requirements  #5206