Effective Quality Systems for Research and Development

About this course

This course will provide a blueprint for how much and how soon for each component of the quality management system. Too much too soon will overburden a research based company and too little too late will jeopardize product approval and put your company and potentially your patients at risk. This course is about ‘getting it right’ – understanding the full scope of the quality management system and integrating with the lifecycle model of pharmaceutical development to offer a phased approach to the implementation of quality management systems.

What You Will Learn

• The philosophy and practice of QA, GMP and QC throughout the product lifecycle
• The essential elements of an effective quality management system based on ICH Q10 guideline
• How firms use QbD to build quality into their products by design
• The importance of change management during R&D
• Why knowledge management is an essential enabler of an effective quality system
• Making effective use of contract manufacturing and testing

Continuing Education Credit

‘Effective Quality Systems for Research and Development’ offers Pharmacists knowledge learning which will provide an understanding of skills, knowledge and process for conducting audits.

ACPE Continuing Education Units = tbc
Reference Activity Number = tbc

Course outline

Quality Management System Background

• The philosophy and practice of QA, GMP and QC embodied in:
  • ICH Q8 – Pharmaceutical Development
  • ICH Q9 – Quality Risk Management
  • ICH Q10 – Pharmaceutical Quality Systems
• The essential elements of an effective quality management system: pre-commercial or development stage
• The essential elements of an effective quality management system: commercial stage

Regulatory Background

• Global clinical supply expectations and their impact on the quality management system
• Key differences between EU and FDA GMPs

Examples of best practices and effective Quality Systems covering the following areas

• Documentation systems
  • Procedures
  • Specifications
• Qualification and validation
• Analytical method validation
• Deviation reporting and CAPAs
• Change management and control
• Vendor management programs
• Contract laboratories and CMO oversight
• Auditing and self-inspection

Current Trends and Expectations

• Management responsibilities
• KPIs and management review
• Knowledge management

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

NSF Health Sciences Boston Office, Boston, MA, USA

These courses will take place in the

The Washington Marriott
1221 22nd St NW
Phone: (202) 872-1500
Washington, District of Columbia 20037
United States

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Mr Jim Morris
  Executive Director
  BA Biol, MSc, MBA

  • [email protected]
  • + 1 857 277 0060
• 

  Dr Peter Calcott
  Consultant
  PhD

  • [email protected]
  • + 1 857 277 0060

What you've said

“I particularly enjoyed the knowledge and stories that Peter shared with the group – very good dynamics kept the course engaging and relevant. Thank you.”

Colette Jue, Genentech, USA

“Good to know that the rest of the industry is on the same page and has the same challenges.”

Anonymous

“I learned a lot and it was especially valuable to get the perspective of people for other types of companies/industries.”

James Banko, Cook MyoSite, USA