GMP Raw Materials Program Risk Management

This GMP (Good Manufacturing Practice) training will discuss strategies to ensure that your resources are deployed to maximize risk reduction, sustain GMP compliance, and respond to exceptions appropriately. Raw materials used in GMP production must be qualified, sourced appropriately, and tested before release into use. Regulations regarding sampling and testing vary globally, creating business and compliance challenges.

Raw materials used in GMP production must be qualified, sourced appropriately, and tested before release into use. Regulations regarding sampling and testing vary globally, creating business and compliance challenges.Raw materials used in GMP production must be qualified, sourced appropriately, and tested before release into use. Regulations regarding sampling and testing vary globally, creating business and compliance challenges.

This talk will discuss strategies to ensure that your resources are deployed to maximize risk reduction, sustain GMP compliance, and respond to exceptions appropriately.

Areas Covered in the seminar:

• Raw materials: define the risks and requirements
• Should you outsource?
• Sampling considerations and sampling plans
• 'Smart' specifications
• Streamlining testing
• Supplier and vendor qualification
• Handling exceptions and changes

Who Will Benefit:

• Development scientists
• QC and analytical methods scientists and managers
• QA directors, managers and personnel
• Manufacturing
• Supply Chain managers
• Purchasing and Materials Control managers