Quality Management Systems
Package ID: PQMS-PKG
Package Geographical Regions: Global
Level : Intermediate
Revisions to the International ICH guidelines Q7-Q8-Q9-Q10- Q11, and implementation of the WHO guideline on Deviation Handling and Quality Risk Management have resulted in major revisions to National and Regional guidelines and regulatory requirements. The six Quality management courses provide14 hrs. of Continuing Education for your CPD and describes the Skills and competencies to provide you with the basis for managing and controlling quality.
To understand and apply Quality Management concepts to decision making in a managerial role for health care provision which will include;
Deviation Handling and Risk Management
Route Cause analysis & CAPA handling
To understand and appreciate the principals of Risk based assessment that is fundamental to quality solutions
Develop robust Product specification by use of Lean Quality by design principals and implement Quality control strategy
Assist in preparing CMC part of CTD registration dossier
Apply the principals of Quality management to the distribution of Medicines
Who Should Enroll:
Regulatory, Manufacturing, Distribution and Quality Assurance Staff.
This Package Includes:
John Dr Jolley FR PHARM S, FCQI CQP
John DR Jolley - FR Pharm S, FCQI CQP is a co-founder of Pharma Consult Global, a Pharmaceutical Consultancy providing technical consultancy and training European countries, Middle East, South Africa and the USA and involving International Pharmaceutical Experts from around the world. He is a pharmacist who has held positions in Clinical Research, Product Registration, Pharmaceutical Manufacturing, Quality Assurance, and General Management. He was Technical Director for Boehringer Ingelheim UK for 15 years before working in Technical consultancy. He is a practicing Qualified Person (QP) for pharmaceutical manufacturing, Distribution and Clinical Research organizations, and is an Industry representative on the EMA advisory committees for GMP/GCP. John has a degree in Pharmacy and has been awarded fellowships with the Royal Pharmaceutical Society and the Chartered Quality Institute.
Shashi Patel DIRECTOR, SOLOPHARM CONSULTANCY LTD. BPHARM(HONS) MRPHRAMS. QP
Pharmacist qualified from Chelsea College, London. Worked in retail and hospital pharmacy thereafter in UK and Saudi Arabia before moving into industry. During that time also did some lecture tours in India presenting best practices in compounding of parenteral drug products and safe practices in aseptic work. Also contributed to several articles in the Pharmaceutical Journal and the Cytotoxic Handbook. First industrial post was with Baxter Healthcare Australia gaining vast experience in manufacture of parenteral products and operation of a compounding unit. On returning to UK became principle pharmacist in running manufacturing unit of hospital which was also a commercial compounding unit. Having become a QP during this period left to join a pharmaceutical company. After 7 years with them following their re-location became a self-employed contract QP and RP to small and large companies. Still operating as a Consultant to the Pharmaceutical Industry 10 years on. Having being involved with different types of organisation as either QP or RP have extensive experience in GMP and GDP. These roles have involved auditing a variety of establishments i.e. laboratories, manufacturing sites for API’s finished products and storage sites.