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An Introduction to Quality Management for Managers Training Course
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.
15 Sep 2022
& 13 Dec 2022 , 27 Mar 2023 , 14 Jun 2023 , 14-15 Sep 2023 , 1 Dec 2023
Details
Course Overview
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.
Who Should Attend
This course will be suitable for Middle Management from the following:
- Production,
- Engineering
- QA
- Technical Support
- Regulatory Affairs
- Supply Chain
- Procurement
- Warehousing
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.
Programme
Introduction and Course Objectives
What is a PQS?
- Key elements
- Role of the PQS
- PQS and Supply Chain Management
Regulatory Requirements
- Key Licensing Requirements
- PQS and the GMP
- How to comply
Roles and Responsibilities of Managers
- Leadership in the PQS
- Legal and operational responsibilities
- The importance of culture and interpersonal skills
Principles and Requirements of The Orange Guide
- Overview and Use of the Orange Guide
- Key principles and their application
Regulatory Inspections
- Preparing for inspection
- Responding to inspection observations
How to Successfully Monitor and Oversee the PQS
- Management Review
- Maintaining a robust PQS infrastructure
Presenter
Rob Hughes (More...)
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”.
During his
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.
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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate
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15 Sep 2022 Live webinar 09:30-17:00 UK (London) |
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15 Sep 2022 Live webinar 09:30-17:00 UK (London) |
GBP 599.00 EUR 859.00 USD 970.00 + VAT @ 20.00% |
Enrol now
to attend Live webinar |
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13 Dec 2022 Face-to-face, Rembrandt Hotel London 09:00-17:00 UK (London) |
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13 Dec 2022 Face-to-face Rembrandt Hotel London 09:00-17:00 UK (London) |
GBP 699 599 EUR 979 839 USD 1,090 934 Until 8 Nov* |
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to attend Face-to-face Rembrandt Hotel London |
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27 Mar 2023 Live webinar 09:30-17:00 UK (London) |
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27 Mar 2023 Live webinar 09:30-17:00 UK (London) |
GBP 649 549 EUR 929 789 USD 1,049 893 Until 20 Feb 23* |
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to attend Live webinar |
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14 Jun 2023 Face-to-face, Rembrandt Hotel London 09:00-17:00 UK (London) |
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14 Jun 2023 Face-to-face Rembrandt Hotel London 09:00-17:00 UK (London) |
GBP 749 649 EUR 1,079 939 USD 1,209 1,053 Until 10 May 23* |
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to attend Face-to-face Rembrandt Hotel London |
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14-15 Sep 2023 Live webinar 13:30-17:15 UK (London) |
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14-15 Sep 2023 Live webinar 13:30-17:15 UK (London) |
GBP 649 549 EUR 929 789 USD 1,049 893 Until 10 Aug 23* |
Enrol now
to attend Live webinar |
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1 Dec 2023 Live webinar 09:30-17:00 UK (London) |
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1 Dec 2023 Live webinar 09:30-17:00 UK (London) |
GBP 649 549 EUR 929 789 USD 1,049 893 Until 27 Oct 23* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.