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Experienced risk assessors

Risk Management

Risk Management Programs
for Product Lifecycle


Quality risk management programs for product lifecycle are recognized by regulatory bodies as an important component of an effective quality system and provide a proactive means to identify and control potential quality issues during development and manufacturing. They can also improve decision making if a quality problem arises and provide regulators with greater assurance of a company's ability to manage risks. Whether for legacy systems or for new product efforts, our experienced consultants can use the full spectrum of risk management tools to streamline your projects and develop phase appropriate risk management programs for your product lifecycle.

Preventive and Procedural Controls

Do you have protective guard rails in place for your product safety programs? During the product lifecycle as processes evolve and suppliers change, product safety programs sometimes fall behind. We can help drive product safety programs and using risk assessment tools identify risks, and design controls and procedural controls that can reduce the residual risk. We will walk with you every step of the way to implement controls that can result in quality, safety, and process improvements.

RISK MANAGEMENT

  • Conduct Risk Assessments

  • Develop Preventive Controls and Procedural Controls

  • Establish product safety programs

  • Review Process Safety programs

  • Develop risk based validation programs

  • Contamination control strategies

RISK BASED MONITORING PROGRAMS

  • Clean Rooms: Environmental Monitoring Program

  • Cleaning Monitoring program

  • Sterilization monitoring program

  • Product and process monitoring program

  • Equipment monitoring program

Our Popular Services


Technical Consulting Services

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CAPAS

Tech Transfer

Risk Management

Validation

CGMP Audits

Patents, Investors

Patent, Investor Support

Fractional R&D, QA Leadership

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