Mentoring, Coaching and Education

A recently licensed medium sized IMP CMO, with a background in R&D, required QP consultancy services to help them develop their maturing Pharmaceutical Quality System.

In conjunction with a QP certification role at the organisation, JWQC provided mentoring and coaching to relatively inexperienced staff to support both increased GMP awareness and continued development of systems to become more robust.

JWQC provided:

• Training and continued mentoring of research based staff on the requirements of clinical phase GMP

• Tailored training sessions on key elements of the Pharmaceutical Quality System. For example, root cause analysis which included working through actual investigations as a result of local deviations and suspected out of specifications

• Documented feedback following each site visit to support the continuous improvement of GMP processes

• QP certification of IMP batches for clinical trial

JWQC worked proactively with the organisation to ensure that new systems continued to develop into robust GMP processes. Increased GMP awareness throughout the organisation facilitated the batch certification process.