Key Services
- QMS support from design to effective operation
- Regulatory inspection readiness activities
- Post Regulatory inspection review and follow up
- Pharmaceutical GMP auditing
Background
Key highlights
- 30 years in the Pharmaceutical Industry
- Underlying philosophies are "keep it simple" and "cost effective quality"
- Worked in multi- national, Japanese, contract manufacturing and virtual organisations
- Built up good relationships with outsourcing organisations.
- Conducted hundreds of GMP audits of all major dosage forms
- Conducted numerous "mock" GMP inspections and assisted with Regulatory Inspection preparation
- Experienced in the manufacture and packing of solid dose, semi solid and sterile products, (including both terminally sterilised and aseptically prepared products).
- Experienced in the manufacture, blinding, packing and labelling of Investigational Medicinal Products for multi-national trials.
- Experienced Qualified Person and Qualified Person Assessor
- Associate of the Link Management Group
Other Services offered
- Qualified Person mentoring and support
- Senior Management workshops
Copyright 2020 Sue Mann Consultancy.