Overview 

This webinar focuses on preparing personnel in case of an unannounced audit. The webinar will cover the following topics:

• Regulatory background and requirements
• Description – what is an unannounced audit and how this compares to regular audits
• The Audit Team
• What to expect on the day
• Audit outcomes
• Common Issues

Learning objectives

The webinar will cover: 

• What an unannounced audit is and why they are required
• What the personnel needs to do in order to prepare for an audit
• How the audit will be conducted and by who
• Outcomes of the audit
  
  

Target Audience

Speaker

Peter Bowness joined BSI in 2012 from industry, where he led projects to develop mesh and injectable collagen implants for guided tissue regeneration and soft tissue reinforcement and bulking in clinical areas such as hernia repair, abdominal wall reconstruction, breast reconstruction, fistula, obesity and soft tissue deformity. Prior to this, Peter worked for a GMP testing laboratory running stability and drug release testing for recombined antibody therapeutics. 

At BSI, Peter is the Technical Team Manager for the Medicinal & Biologics Team with responsibility for devices utilising materials of animal origin and drug/device combination products. Peter is also a technical specialist conducting conformity assessments for devices utilising materials of animal origin, surgical implants and surgical instruments.  In addition, Peter is chair of the British Standards technical committee for symbols and labelling in medical devices and a member of the UK technical committee for risk management in medical devices. Peter holds a BSc (Hons) in Biomedical Sciences specialising in Medical Biochemistry and a PhD in Molecular Genetics and Protein Chemistry. 

CPD

This course offers 1 CPD hour for successful completion. To learn why CPD is important visit our Lifelong Learning page.

How do I register?

Prices

Discounted Places

A limited number of discounted places are available at the rates below for those:

• in low income countries as defined by the World Bank
• working for agencies, charities or NGOs. 

Please email meetings@topra.org for a discount code before making your booking.

* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

By purchasing this webinar, you are agreeing to the terms and conditions.