Date: Available on demand. (Original presentation date: 26 January 2020)

Overview

This webinar will cover:

• 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

From this webinar you will be able to understand:

• what an unannounced audit is and why they are required
• what they need to do to prepare for an audit
• how the audit will be conducted and by who
• the outcomes of the audit

Target audience

Any manufacturer personnel in a management position.

Presenter 

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 recombinant 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 about why CPD is important visit the Lifelong Learning page.

Price 

Members: £70+VAT

Non-members: £95+VAT

Access

Once you have purchased the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase. 
Please note, if you select the pay later option, you will not have access until payment has been cleared.

Terms and conditions

Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.