Presented by
Management Forum
Quality Management Refresher Training Course
Keeping up-to-date with your legal and operational responsiblities
This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.
18-19 May 2023
+ 1 more date
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
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. Effective design, implementation, maintenance and monitoring of the PQS are important in meeting customer needs.
This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management.
It will also provid e a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.
This is an excellent opportunity to hear from an experienced QP and discuss the challenges of Quality Management and its successful application.
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
Benefits in attending
- Keep abreast of the latest regulatory requirements
- Know your legal and operational responsibilities
- Understand the key principles of 'The Orange Guide' and their application
- Review how to respond to inspection observations
Who should attend
This course will be suitable for all experienced personnel who need to keep up-to-date with the latest requirements, including those working in the following departments:
- Production
- Engineering
- QA
- Technical Support
- Regulatory Affairs
- Supply Chain
- Procurement
- Warehousing
Attendance by Qualified Persons is recommended.
The Quality Management Refresher course will cover:
Introduction and course objectives
Our customers
- How to meet their needs
Regulatory requirements
- Overview of legal requirements and recent developments
- Key licensing requirements
- PQS and the GMP
- How to comply
The Pharmacuetical Quality System (PQS)
- What is a PQS?
- Key elements
- Role of the PQS
- PQS and Supply Chain Management
Roles and responsibilities
- Leadership at all levels in the PQS
- Legal and operational responsibilities
- Culture and the PQS
Principles and requirements of 'The Orange Guide'
- Overview and use of 'The Orange Guide'
- Relationship to legal requirements
- Key chapters
- Key principles and their application
Regulatory inspections
- Preparing for inspection
- Regulatory trends
- Responding to inspection observations
Q & A
- Review of key points
- Questions and discussion
Rob Hughes
Rob Hughes Associates
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.
Book Quality Management Refresher Live online training
NEW higher discounts for multiple bookings - 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*
Please contact us for pricing if you are interested in booking 5 or more delegates
18-19 May 2023
Live online
13:30-17:30 UK (London) (UTC+01)
14:30-18:30 Paris (UTC+02)
08:30-12:30 New York (UTC-04)
Course code 12143
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 13 Apr
- 2 sessions of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
28 September 2023
Live online
09:15-17:00 UK (London) (UTC+01)
10:15-18:00 Paris (UTC+02)
04:15-12:00 New York (UTC-04)
Course code 12312
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 24 Aug
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* 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.
