SeerPharma UK

This course is accredited for 7 CPD points

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

• Former MHRA Inspector led sessions and exercises.
• 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.