This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.
13 Dec 2022 + 4 more dates
The manufacture of pharmaceutical products requires the establishment and implementation of an effective ‘Pharmaceutical Quality System’ (PQS). The concepts of QA, GMP and Quality Control (QC), which are inter-related, form the basis of such a system for the manufacture of pharmaceutical products from initial development, through clinical phases to commercial and supply.
This seminar has been designed to provide a highly interactive introduction to Quality Management for managers and will provide the opportunity to share and consolidate the key elements of the Pharmaceutical Quality System (PQS). It will describe the roles and responsibilities of middle and senior management in the PQS and provide practical advice and guidance on how to ensure legal and operational responsibilities are fulfilled.
The seminar will also consider the importance of effective leadership and how leaders demonstrate the behavioural standards required for an effective “quality culture” that supports the PQS.
The seminar will also provide a comprehensive overview of the essential principles and requirements of the “Orange Guide” and other relevant regulatory requirements.
This course will be suitable for Middle Management from the following:
It will also be appropriate for Senior Management, including the head of any department who is a member of a site senior team, including departments listed above as well as HR and Finance.
Rob Hughes has worked in the pharmaceutical industry for more than 35 years.
Rob started his career in control laboratories before gaining accreditation as a “Qualified Person”.
career, he has held operational, project and senior strategic
leadership positions in commercial manufacturing and development QA. Rob has experience of the application of quality assurance in control laboratories, active substance, solids, creams and liquids manufacture, supplier evaluation and in regulatory inspections.
In the strategic roles, Rob was responsible for the leadership of global groups, which developed and rolled out quality systems across the company network of sites.
Rob spent two years in R&D project management with a focus on the reduction of development timelines, prior to establishing his consultancy in 2012.
Since then, Rob has worked with many different companies in the development, remediation and implementation of quality systems, training of staff from operator to management level and auditing of quality systems.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
13 Dec 2022
09:00-17:00 UK (London)
Course code 12072
Until 08 Nov
27 Mar 2023
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12522
Until 20 Feb
14 Jun 2023
09:00-17:00 UK (London)
Course code 12201
Until 10 May
14-15 Sep 2023
13:30-17:15 UK (London) (UTC+01)
14:30-18:15 Paris (UTC+02)
08:30-12:15 New York (UTC-04)
Course code 12313
Until 10 Aug
1 Dec 2023
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12666
Until 27 Oct
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: