About this course
Quality System Performance Measures – How Good is Your Quality Management System?
The quality of your product is determined by the effectiveness of your quality system and the people operating it. Unfortunately, many quality systems have become so complex, slow and bureaucratic they no longer meet regulatory expectations and the low cost ‘efficiency’ demands of your business.
To remain ‘regulatory compliant’ and reduce costs you must simplify and improve your quality system. To do this you must have accurate measures of performance, without which any improvement is impossible. This course will provide you with very practical guidance on:
- How to select simple, accurate and reliable performance indicators for your quality system
- How to quickly interpret and report the data and information to
- reduce risks to your business and your patients
- improve your regulatory compliance
- reduce your quality system costs
- simplify your quality system
Our objective is to provide you with practical tools and techniques to dramatically improve the compliance and efficiency of your quality system.
What You Will Learn
- How to select the 20% of measures that provide 80% of ‘value adding’ information. Remember, less is more!
- How to select performance measures that
- are accurate
- are simple
- are reliable
- improve the performance of your quality system
- How to easily collect and present information in the most interesting and user friendly way
- How to review report and act on the data within days, not weeks or months
- How to use performance data to drive continuous quality and compliance improvements and to motivate your workforce
- How to ensure that the performance measures actually result in genuine and lasting improvements, and are not filed and forgotten
Course outline
The course will show you which performance measures to select for key elements of your quality system and how to use the data to improve performance, including:
- Manufacturing processes and operations (including equipment performance)
- Documentation systems and SOP compliance
- Product release activities and the batch manufacturing record review and approval process
- Change control systems
- Deviation reporting and CAPA systems
- Planned preventative maintenance and calibration systems
- Training and people ‘performance’
- Management and control of contractors and ‘third parties’
- The internal audit and self-inspection programme
- Customer complaints
- Quality control activities (chemical and microbiological)
Venue
Glen Hove Conferencing, Johannesburg, South Africa
Glen Hove Conferencing is centrally located in Johannesburg and close to the very popular Melrose Arch Complex with its superior hotels and dining facilities. Glen Hove Conferencing is the headquarters of the Southern Gauteng branch of the South African Pharmaceutical Society.
For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]
The courses will be held in the ultra modern Upper Glen Hove meeting room which can comfortably seat 80 persons. Acoustics in the room are excellent as is the standard of catering facilities provided. For further information please visit the conference centre’s own website at www.glenhove.co.za or email them at [email protected]
Catering
During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet served in the foyer.
After each day’s activities a closed bar service will be available, chargeable to your account where relevant.
Special Dietary Requirements
If you have any special dietary requirements, please contact the conference management.
Venue Address and Contact Details
Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 2196
PO Box 2467, Houghton, 2041
Tel: 011 442-3601
Fax: 011 442-3678
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
These are just some of the comments we have received and are typical of the kind of feedback we have come to expect after an NSF-DBA course.
“Eye opening!”
Kees Piket, Solvay, The Netherlands
“Great tutors, great material, great course!”
Michael Kirk, Cara Partners, Ireland
“Course extremely beneficial and value adding.”
Shannon Bearpark, Shire Pharmaceuticals, UK
“As with all DBA courses – great course atmosphere.”
Karin S-Ohlson, Polypeptide, Sweden
“Fantastic course – incredibly knowledgeable course tutors.”
Claire Nickless, sanofi aventis, UK
“Taught me more than I ever expected.”
Novi Holvast, NVI Vaccines, The Netherlands
“Very good tutors – provided excellent answers and solutions to real life problems.”
Jef Van der Leij, NV Organon, The Netherlands
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