Effective Quality Systems for Research and Development
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This course will provide a blueprint for how much and how soon for each component of the quality management system.
Dates:
Tuesday 12 to Wednesday 13 November 2013
Venue:
San Mateo Marriott San Francisco Airport, San Mateo, CA, USA
Cost:
$1775.00 (first booking)
$1420.00 (additional bookings from same site or early bird booking)
Type: Pharmaceutical
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
San Mateo Marriott San Francisco Airport, San Mateo, CA, USA
The San Mateo Marriott San Francisco Airport Hotel is is located just 10 minutes from San Francisco International Airport and offer complimentary shuttle service. It has convenient access to San Jose and San Francisco and is also less than 30 minutes from the Golden Gate Bridge.
Hotel Accommodation
NSF-DBA has negotiated a preferred rate with the San Mateo Marriott San Francisco Airport 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
San Mateo Marriott San Francisco Airport Hotel,
1770 South Amphlett Blvd,
San Mateo,
California 94402,
USA,
Tel: +1-650-653-6000
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:
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
