Effective Pharmaceutical Quality Management Systems

About this course

This course will provide a blueprint for how much and how soon for each component of the quality management system. It builds on the key enablers of ICH Q10 namely the effective application of knowledge management and risk management. We know that applying full blown Quality Management Systems too soon will overburden a researchbased company and yet applying Quality Management Systems too late will jeopardize product approval and put your company and potentially your patients at risk. Achieving the right balance and applying Quality Management Systems judiciously throughout the product lifecycle to achieve product realization is what this course will cover.

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 Pharmaceutical Quality Systems
• How firms use QbD, knowledge management, and riskbased decision making in development
• 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 = 1.4 CEUs
Reference Activity Number = 0616-0000-11-011-L04-P

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

Boston Marriott Cambridge, Cambridge, MA, USA

The Boston Marriott Cambridge is situated across the Charles River from downtown Boston and is the perfect location for your next visit to the city. This Cambridge hotel is positioned in Kendall Square near popular Boston area attractions.

Hotel Accommodation

NSF-DBA has negotiated a preferred rate with the Boston Marriott Cambridge Hotel. A limited number of rooms are available at this rate. Hotel reservations and payment are the responsibility of each delegate.

We will be happy to help but final confirmation and bill settlement is the delegate’s responsibility.

Venue Address and Contact Details

Boston Marriott Cambridge,
2 Cambridge Center,
50 Broadway,
Boston,
Massachusetts 02142 USA,

Tel: +1-617-227-0815

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:

• 

  Mrs Luba Skibo
  Executive Director
  M.S. Agricultural Chemistry, M.S. Analytical Chemistry

  • [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