The Ferer Group Consulting Services

Quality Assurance and cGMP Compliance

For many projects and clients, I have been responsible for ensuring compliance with US and EU regulations (occasionally Japan, Australia and Canada). Within this role, I developed quality programs and verified compliance to those programs both through audits as well as reviewing and approving documentation. As a quality assurance specialist, I directly interfaced with regulators from the US, UK, and Japan as a regular part of an assignment.

For these types of projects, I use my expertise in understanding regulatory expectations and translating that understanding into practice by ensuring that my clients have a sound, science-based, and regulatory-justified solution to compliance.

In two recent projects, the final results were obtaining approval to produce and ship product. On one recent project we received a favorable inspection on a project where I interfaced with the design, engineering, and operations team as the lead quality assurance representative. On another project, I defended the facility design and equipment qualification approach to the MHRA investigator resulting in obtaining licensure.