This course is accredited for 7 CPD hours

A course to develop knowledge and experience at a management level. The WDA Licence Holder is required to have a high level of knowledge to ensure obligations and regulatory requirements are met. Key obligations include outsourcing, provision of suitable equipment and facilities, providing adequate resources, provision of a Quality Management System and appointing a Responsible Person.

Key topics

Effective assessment of the RP
Outsourcing pros and cons
The Cost of Quality
Provision of the Quality Management System (QMS)
The benefits and disadvantages of an eQMS
Designing systems to reduce criticality
Jargon Busting
Inspection readiness
Discussions to embed learning

Course Objectives

Ensure management can effectively support staff in achieving compliance
Support pragmatic decision making in provision of supporting functions
Enable interaction with a former MHRA inspector to understand the right approach to avoid regulatory impact
Provide opportunities to engage with management from other pharmaceutical companies
Highlight importance of management involvement in quality and compliance

Expected Course Outcome

Those attending will:

Gain a better understanding of the relevance and requirements of GDP and the Human Medicines Regulations
Understand their role in using compliance as a business driver
Develop sufficient knowledge to safely and effectively delegate decision making
Have a greater understanding of licensing and inspection requirements
Effectively deliberate key issues with other industry representatives

Special features

The courses will be presented by the SeerPharma UK team, comprising of former MHRA Inspectors and industry experts
Practical, pragmatic approach to training, using real-world examples
All delegates will receive comprehensive course documentation
Certificate of Attendance issued by the trainers
Interactive learning approaches, with open questions

Training audience

The Training Course is designed for the WDA licence holder and senior management who may have an indirect impact on regulatory or quality.

The course will be adapted to meet the needs of those attending whether from micro or SME companies, or large pharmaceutical manufacturers with a distribution function.

The approach used is suitable for companies facing regulatory action and also for companies aiming to maintain and improve their current compliance status.

LinkedIn SeerPharma UK Closed Group Members contact Debra.Stanfield@seerpharma.co.uk

Prices

Prices are displayed without VAT. VAT will be added at the point of registering for a course.

Outside the UK? Contact Debra.Stanfield@seerpharma.co.uk for VAT-free registration.

WDA Licence Holder - GDP and Licence Obligations