DAY 1 – Monday, June 29, 2020

Enhance Your Supplier Qualification and Auditing Program
12:00pm EDT

  • Outline the critical aspects, and importance of, a robust supplier qualification program
  • Develop checklists for vetting and assessment of supplier and contractors
  • Assess how to make sure your suppliers are compliant with relevant regulations and standards
  • Discuss the challenges of a remote audit and how to ensure it is effective
  • Discuss incorporating supply chain into the decision making process for initial qualification and updates
  • Consider what suppliers to audit and how to audit them – audit checklist necessities for different systems and processes
  • Develop protocols for acceptance when the supplier is the only source


Adrienne Leyland
Sr. Manager Quality Assurance
Atlas Pharmaceuticals

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DAY 2 – Tuesday, June 30, 2020

Improving Quality through Training - Innovative Approaches to a Culture of Continuous Learning and Improvement
12:00pm EDT

  • Outline the limitations of standard forms of training and education for pharmacy operators
  • Demonstrate the importance of consistency and compliance in the pharmacy using case examples of non-compliance
  • Highlight new, more engaging forms of compliance training and how they can be incorporated
  • Discuss how technology can be leveraged to track and ensure compliance and consistency among operators
  • Underline the importance of a creating a culture that enable continuous learning and quality improvement
  • Compare activities and procedures that help achieve and maintain this continuous learning culture


Seth DePasquale
Co-Owner and Pharmacist-in-Charge, BET Pharm

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How Automated Robotic Technology in aseptic filling can solve sterility issues and much more
1:00pm EDT

AST VP of Business Development Matthew Gorton will provide an analysis of the issues that are driving compounding facilities to invest in automation. The Pharmaceutical Industry has been leveraging automation and robots for years, and there is a growing need for compounding pharmacies to follow this path to ensure sterility and minimize compounding errors based on the recurring issues with recalls and sterility.

Leveraging an automated system to perform error prone and somewhat risky tasks such as aseptic filling of your sterile products, can have a big impact on your patients as well as your bottom line.

Modern systems are often integrated with electronic records which collects information/ data on production and environmental monitoring to help support their compliance to the updated USP 797 regulations.

The presentation will demonstrate how automation can benefit your business and customer’s patients. We will highlight the impact of regulation and market forces and will conclude with a brief introduction to AST and their product line.


Matthew Gorton
Vice President of Business Development
Automated Systems of Tacoma

Matthew Gorton is Vice President of Business Development at Automated Systems of Tacoma, a United States based solutions provider focused on flexible filling solutions for small-batch applications including compounding pharmacies as well as advanced biotech companies.
Matthew transitioned his career into the pharmaceutical industry in 2014. For the past 6 years he has been entirely focused on providing solutions to the manufacturers of sterile injectables.
Matthew is an active member in the industry and currently holds several leadership positions in the International Society of Pharmaceutical Engineering, including: Chairing the Sterile Products Processing Community of Practice, Co-Chair of the Knowledge Network, and editor of the ISPE magazine, Pharmaceutical Engineering.
Matthew holds a Bachelor of Science in Biology from Truman State University, and an M.B.A. from the University of Minnesota Carlson School of Management.

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DAY 3 – Wednesday, July 1, 2020

Investing in a Culture of Quality from the Ground Up
12:00pm EDT

  • Define a culture of quality in a 503a Pharmacy
  • Review the needs of a 503a Pharmacy Total Quality Management Program
  • Understand the challenges and opportunities when creating a quality of culture
  • Discuss the needs for growing and sustaining the quality of culture in a 503a Pharmacy


Alexander Pytlarz
Vice President of Operations
Infuserve America

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Process Development and Validation Life Cycle
1:00pm EDT

  • Quality by Design Approach
  • Process design risk assessment
  • Strategies for initial process validation
  • Continuous quality improvement
  • Regulatory framework of validation


CEO and Principal Consultant
AMICUS cGMP Consulting

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