Expert navigators for the complex world of bioprocessing  
 

Services - Consulting and Industry Navigation

The BioProcess Institute provides high value consulting services to help you meet your business objectives. They are primarily in the areas of:

  • Bioprocessing Engineering;
  • Operations Management; and
  • Current Good Manufacturing Practices (cGMP)

The BioProcess Institute offers a pragmatic, balanced approach to addressing our clients' needs. We're not seeking infinite billable hours and an endless consulting partnership. Our industry experience has provided us with the capability of attaining quality over quantity in every aspect of the services we offer. We are looking for solutions and success for our clients by the most concise and efficient methods possible.

“The wind and the waves are always on the side of the ablest navigators.”
- Edward Gibbon

 

BIOPROCESS
ENGINEERING
  OPERATIONS
MANAGEMENT
  CURRENT GOOD MANUFACTURING PRACTICES (cGMP)
         
   
  • Single-Use Adoption/Conversion
  • Strategy and Risk Assessment
  • Standards and SOP Development
  • Rouge Predictive Maintenance for Utilities and Process Equip.
  • Steam Quality Testing
  • Change Control Strategy, Implementation and Close-out
  • Technical Investigations
  • Quality by Design
  • Cost of Change
  • Subject Matter Expert (SME)
  • Facility Reviews
  • Process Reviews
  • Equipment Reviews
  • Project Justification
  • Technical Information Support
  • Data Analysis and Control Charting
  • Rouge Predictive Maintenance Program
  • Single-Use Component Information Management Systems
  • Standards and SOP Development
  • Quality-by-Design
  • Failure Analysis
  • Root Cause Investigation

 

 
  • Staff Consensus Facilitator
  • Cost of Change
  • Facility Reviews
  • Project Justification
  • Single-Use Component Information Management Systems
  • Expert Witness
  • Third Party Opinion Leader
  • Arbitration
  • Facilitation
  • Leadership and Management
  • Staff Development and Personal Coaching
  • Recruitment Strategy
  • Candidate Screening
  • Position Description Generation and Benchmarking
  • Organizational Strategy to Meet Business and Operational Needs
  • Risk/Benefit Process Evolution
  • Process Optimization

 
  • Change Control Strategy, Implementation and Close-out
  • Technical Investigations
  • Regulatory Investigations
  • Subject Matter Expert (SME)
  • Project Justification
  • Single-Use Component Information Management Systems
  • Standards and SOP Development
  • cGMP Risk Assessment
  • Environmental Monitoring
  • Root Cause Investigation
  • NC/CAPA Support
  • EMEA/FDA/ISPE Expertise
  • FDA 483 Remediation Expertise
  • Mock Auditing and Audit Coaching


CONGRATULATIONS

James D. Vogel

for winning the BioProcess International's Industry Champion Award!

 Click HERE to read about it 

 

PRESS BOX



BPI is proud to introduce BioProcess Performance Reports!
Click Here to Read More


 
The BioProcess Institute | 376 Dry Bridge Rd, Unit H-3 | North Kingstown, RI 02852 | 401.294.9000