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IPS

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Charles Stock, MBA, CxA, Lean Certified

Sr. Consultant

Compliance Expert

Areas of Expertise

  • Manufacturing Operations
  • Medical Device and Biotechnology operations
  • Risk Assessments 
  • Process Development / Quality by Design
  • Technology Transfer
  • Process Validation
  • Facility and System Start up, Commissioning and Qualification
  • Project and Validation Planning
  • Lean Engineering and Qualification practices
  • Quality System Implementation

 

Helping our clients achieve their business goals in this dynamic environment is why we are here.

- Charles Stock
Sr. Consultant

Charles is an industry expert that offers more than 35 years of technical, compliance and process/operations experience in the technical manufacturing industries. 

Charles has been an integral part of IPS and is currently the Sr. Vice President of Validation.  He has developed and presented training programs for C&Q project planning, quality systems, leaning out capital projects, development of operating strategies and performing risk assessments.  His operations and start up experience encompasses medical device, biotechnology, aseptic/sterile, OSD, and specialty dosage form facilities. 

“Being part of the Technology Tours is a great experience for me.  I get to learn from owners, vendors and service providers in an environment that serves that purpose for all involved.” “The only source of knowledge is experience” (Albert Einstein)

Recent presentations include:

Applied QbD Hybrid Approach, A Case Study: Process Characterization, Roadmap and Validation For a Fast Track (Orphan) Biological Therapeutic in a Virtual Company”, OMICS Sept. 2014 & ISPE Biotechnology Seminar, August 2013, Raleigh, NC

Implementing a Periodic Validation Review Program, A Case Study Based Application” OMICS Sept. 2014 & ISPE Biotechnology Seminar, August 2013, Raleigh, NC 

Modern Commissioning and Qualification for FDA Regulated Facilities”, Presented to Numerous Biopharmaceutical Manufacturers at Sinopharm offices, April 2014, Shanghai, China

Good Engineering Practice”, Presented to Sinopharm GepTech Engineering, April 2014, Shanghai, China

  • p. 888.366.7660

Recent Projects

  • Site Change Risk Assessment and Technology Transfer
  • Implementing a Modern Quality System
  • Potent Suite Risk Assessment
  • ASTM E-2500 implementation at a Sterile Manufacturer
  • In-house vs CMO business case
  • Implementing QbD approach for fast-track product