Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)

ComplianceOnline, Singapore
2019-04-02

This “State of Control” is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990’s the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated in a series of Quality Guidances under the banner of the International Conference on Harmonization (ICH). The ICH guidances that cover Quality aspects (listed Q1 through Q12) define the high level expectation for maintaining a State of Control.

This course will cover those ICH Guidances related to the Quality Systems for manufacturing:

• ICH-Q7: cGMPs for Active Pharmaceutical Ingredients
• ICH-Q8: Quality by Design for introducing new or generic products into manufacturing
• ICH-Q9: Risk Assessment and the role of assessing Risk in the development, manufacturing, testing and supply chain of drugs.
• ICH-Q10: Quality Management
• ICH-Q11: Development and Manufacture of Drug Substances

In addition certain aspects of the USFDA’s and EMA’s laws will also be cove

Learning Objectives:

Upon completing this course participants should:

• Understand the history and expectations for global regulators for Quality Management and a State of Control
• Understand the vocabulary Quality Management including expectations for a “Quality Culture”
• Understand aspects related to Quality Management from the following sources:
  • ICH-Q7 GMPs
  • ICH-Q8 Quality by Design for new and generic drugs
  • ICH-Q9 Risk Management
  • ICH-Q10 Pharmaceutical Quality System
  • ICH-Q11 Development & Manufacture of Drug Substance
  • 21CFR 210/211/820 for GMPs
  • 21CFR 314 for Post Market Surveillance
  • 21CFR Part 11 & Annex 11
  • MHRA’s Guidance on Data Integrity
• Understand the role and importance of Documentation
• Understand the interaction and integration required for successful GMP operations
• How to prepare and present the State of Control to investigators during an inspection

Who will Benefit:

This course is designed for people throughout the GMP Operations with a focused emphasis on the Plant & Global Quality Units; Departmental Heads, Managers & Supervisors; and Plant Management. In addition, all GMP operations personnel could benefit, especially those selected SMEs within the organization who will face the inspectors.

Following personnel will benefit from the course:

• Executive Management
• Plant and Global Senior Quality Managers
• Plant and Global Quality Professionals
• Plant and Global Regulatory Professionals
• Plant and Global Compliance Professionals
• Production Managers, Supervisors and Operators
• Manufacturing Managers & Supervisors
• Warehouse Managers and Supervisors
• Calibration, Preventive Maintenance and Production Supervising Engineers
• Process and Department Owners
• Quality Engineers
• Quality Auditors
• Deviation & CAPA System Personnel
• Plant and Global Designated Investigators and Process Improvement Personnel

Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, regulatory, compliance and business challenges. His broad knowledge includes serving in Executive and Quality Management for multi-national corporations, biopharma start-ups and established pharmaceutical enterprises. Years of direct hands on involvement provide specific abilities to assist life science companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals within a context of good science and FDA / EU compliance. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.

Mr. Reaney has spent many years in India immersed in the diverse cultures and unique ways of business: As a teenager, he lived for several years with his parents in Hyderabad when his father worked for UNDP introducing technology for the nascent Indian Sponge Iron industry; after his university studies, he returned to India on a Fulbright Scholarship for two years; then in 2007, he and his wife moved to Indian and have been working with and mentoring Indian, US & EU companies who have operations in India and abroad for GMP manufacturing of API, OSD and Parenteral Formulations and for Biotech manufacturing.