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GMP (Good Manufacturing Practice) Fundamentals Training Course
This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.
18-19 Oct 2022
Details
Overview
Pharmaceutical manufacturers are required to meet and maintain Good Manufacturing Practice (GMP) as a condition of the licence granted by the regulatory authorities.
The manufacture of pharmaceutical products requires the establishment and implementation of a ‘Pharmaceutical Quality System’ (PQS). The concepts of QM (Quality Management), GMP and Quality Control (QC), which are inter-related, form the basis of such a system for the manufacture and testing of pharmaceutical products from initial development, through clinical phases to commercial and supply. Hence, the delivery of GMP requires the establishment and implementation of an effective PQS.
This two-day seminar will consider the relationship between the legal requirements for pharmaceutical manufacture, the PQS and the delivery of GMP. It will provide a highly interactive session to discuss the key elements of the PQS and the relationship with GMP as described in the “Orange Guide”, including the practical application of GMP in manufacturing and quality control.
Benefits in Attending
- Understand the legal requirements and how to comply
- Learn the key elements and role of the PQS
- Know your operational responsibilities
- Gain insight in to the principles of the ‘The Orange Guide’
- Understand the key requirements of CAPA and Change Control
- Consider the key elements of supply chain management
- Get an introduction on how to prepare for regulatory inspections
Who Should Attend
This course will be suitable for all personnel in the pharmaceutical industry who have limited or no experience with the current GMP reqiurements working in the following departments:
- Production
- Engineering
- Quality Assurance (QA)
- Technical Support
- Regulatory Affairs
- Supply Chain
- Procurement
- Warehousing
It will also be beneficial to Qualifed Persons, and experienced personnel who are working for the first time in a GMP regulated environment. In addition, it will be useful to suppliers who have to understand the quality requirements of their customers.
Programme
Introduction and course objectives
Our customers
- How to meet their needs
Regulatory requirements
- Overview of legal requirements
- Key licensing requirements
- PQS and the GMP
- How to comply
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
Deviation and CAPA management
- Key principles
- Practical application
Change control/management
- Key principles for an effective system
Complaints and recalls
- Key requirements
- CAPAs
Supply chain
- Management of suppliers of materials, product and services
- PQS considerations
Regulatory inspections
- Preparing for inspection
- Regulatory trends
Management review
- Maintaining and improving the PQS
- Regulatory trends
Q & A
- Review of key points
- Questions and discussion
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.
Book now
Book now
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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18-19 Oct 2022 Live webinar 09:30-17:00 UK (London) |
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18-19 Oct 2022 Live webinar 09:30-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 13 Sep* |
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.