Whether operating in accordance with GCP, GLP, GMP, GDP, GPvP, GPP or GEP, there are particular processes and tools which are fundamental to efficient and effective management

Ann McGee Consulting can help you to improve your core competence in these areas and to weave them intrinsically into your approach to Quality Management

Quality Risk Management (QRM)

• We can help you to translate regulatory requirements for QRM into a practical philosophy for day to day working

• We can help you to define quality objectives, goals and key performance indicators (KPIs) that reflect your business risks

• We can prepare a Quality Policy Manual that defines your approach to assuring product quality and to minimising risks to product quality

• We can help you to redefine your ‘Quality Mission, Vision and Values’ to reflect the concepts and principles of QRM

Process Mapping.

• We can facilitate  the mapping of key processes to ensure the best use of resources, minimising duplication and eliminating critical process hold-ups

Organisation Design

• We can support and evaluate the suitability of your organisation’s structure to meet regulatory requirements and best practice standards

• We can analyse current roles and responsibilities and recommend improvements in order to meet regulatory requirements and best practice standards

• We can assist in the definition of roles and responsibilities for key positions within your Quality organisation and participate and support a recruitment process