Our Team
Meet the independent experts that work closely with STEP Change Pharma.
Dr. Ali Afnan
Founder and CEO
Dr. Ali Afnan began his career in ICI Engineering as a control-electrical engineer, and then joined the engineering group in AstraZeneca. There he led the development and implementation of a PAT framework for a solid dosage facility- the first such facility in industry.
Dr. Afnan was recruited in 2003 by FDA to join the Agency’s PAT and Drug Product Quality initiatives. He was a member of the PAT steering team, a co-author of the PAT Guidance, and a member of the core team responsible for authoring and finalizing the most recent Guidance from FDA on Process Validation. He left the FDA in March 2010. He is the recipient of several FDA Commissioner awards, as well as the Industrial Pharmaceutical Federation’s Industrial Pharmacy Medal of Excellence award.
Alicia Viehmann
Consulting Manager
In her current role as Consulting Manager, Alicia performs multiple duties ranging form compliance remediation to program management. Alicia has a proven history of solving complex problems and assisting in implementation of various novel processes. She excels at creating excellent client experiences and improving organizational effectiveness. Prior to joining Step Change Pharma, she worked as an analytical research chemist with Supernus Pharmaceuticals and later transitioned to a role in healthcare. Alicia earned her B.S. in Chemistry from the University of Maryland, College Park.
Leverage the power of Step Change Pharma's extensive network. Our team of highly qualified, seasoned consultants and specialists offer proven expertise to deliver long-term success.
Our expertise spans the entire pharmaceutical operations spectrum, from development and manufacturing to quality control, supply chain management, and distribution. We deliver a comprehensive suite of solutions designed to optimize your processes and drive success.
Step Change Pharma optimizes your pharmaceutical operations from top to bottom. We leverage our team of experienced consultants to deliver expertise in:
Quality Management Systems: Assist with QMS development, implementation and remediation, ensuring your systems are robust and compliant.
Facility & Operations Oversight: Provide comprehensive oversight of your facilities and operations, including batch release support.
Micro & Environmental Control: Assess and assist in developing and/or improving microbiological and environmental systems, including operations, investigations, and troubleshooting.
Data Integrity Champions: From concept to implementation, we help you establish data integrity procedures and systems, as well as assess data for potential issues.
Inspection Readiness: We prepare you for regulatory inspections with mock audits, on-site support during an inspection, and provide guidance on responding to observations and deficiencies.
Training & Development: We offer targeted training programs to equip your team with the necessary skills.
Statistical Process Control (SPC): Our experts implement SPC systems, assess processes, and streamline process validation and continued process verification.
QC Laboratory Support (Biologics & Small Molecules): We provide comprehensive QC lab support through audits, method assessments, and troubleshooting.
Process Control System Implementation: Help implement real-time process control and develop continuous manufacturing capabilities.
Expert witness in litigations
