Whether it be a short term need to alleviate a backlog or a long term need to provide ongoing services, Ardent Consultants partner with clients to provide the experience and expertise.
Quality Assurance and Compliance
Our consultants have the expertise to perform the following:
Audits & Remediation
Self-Inspection is a regulatory requirement. Also, before initiating GMP activities with a vendor, it is expected that a vendor assessment includes an audit of the Quality Systems and controls. Our consultants are experienced with the Audit process and can do the following:
Staff require the necessary training in the areas in which they are performing GMP activities. The training must typically be done when a new employee is on-boarded or a new or revised Standard Operating Procedure (SOP) is being implemented. It is a requirement for staff to complete training prior to executing the respective procedures.
The training methods used can vary, but typically the training can be done in person with an assessment tool, e.g. quizzes or reading and acknowledging the understanding of a procedure. Quizzes for training on a procedure and a formal written assessment of the individual perform a task from a procedure are typically the best methods. Our Consultants can develop and assist with the GMP training which is an annual requirement. They can also ensure that the training is done efficiently.
Standard Operating Procedures
Generally, SOPs are written by authors who are deemed as experts within their areas of function. Ardent Consultants have the experience and knowledge to provide the following services: