Quality Compounding Consultants

Your partners in achieving certification and compliance!

Services


  • Compliance Audits
  • SOPS for PCAB/ACHC Certification
  • SOPs for 503A Pharmacies and 503B Outsourcing Facilities
  • Preparation for FDA Inspections
  • Preparation for PCAB/ACHC Certification
  • Training Materials for Pharmacy and 503B Outsourcing Compounding Personnel
  • Cleaning Programs for Pharmacies and 503B Outsourcing Facilities
  • Gap Analysis for Pharmacies and 503B Outsourcing Facilities
  • Environmental and Personnel Monitoring Program Development
  • New Pharmacy or 503B Outsourcing Facility Planning and Development
  • General Consulting Services for any aspect of the Pharmacy Compounding or 503B Outsourcing

We are committed to a lasting partnership!


Your personalized consultation begins with an introductory meeting or phone call to learn about your business needs. A tailored program will be developed for your facility that encompasses your goals and the educational and regulatory requirements needed for compliance. Standard operating procedures can be provided that are custom written for your facility and will reduce the amount of time your staff will spend editing templates. The consultant will meet with key leadership before and after the consulting session to ensure your needs are understood and met on a timely basis.

About Us


Linda Cappellini Stizza

R.PH., FIACP, FACA

Quality Compounding Consultant Linda Cappellini


Linda Cappellini Stizza has 19 years of experience in non-sterile and sterile pharmacy compounding and outsourcing compounding.

Linda was involved in all phases of the compounding pharmacy and outsourcing planning as well as SOP development, training, quality systems, and compliance auditing. She has worked with microbiologists in developing environmental and personnel monitoring programs that are FDA compliant. Linda has prepared pharmacies for FDA, PCAB, ACHC, NABP, and State Board of Pharmacy audits and has been a key team member interacting with the inspectors during the audits.

Linda was awarded the Scheffe Scholar designation by the American College of Apothecaries and designated as Preceptor of the Year by Midwestern University College of Pharmacy. She received the Philosophy in Action Award for Quality and Excellence for improving the cost effectiveness and quality of pharmacy services at Catholic Healthcare West.

Ready To Get Started!


Give us a call or send us an email and we will get back to you as soon as possible!




6O2-51O-3886