How to Audit - Key Excipients

About this course

Many experienced auditors find they have to audit areas which they are unfamiliar with; in addition, experienced auditors should always be seeking opportunities to keep up-to-date through continuing professional development. As part of our ‘How to Audit’ series, providing hands-on practical courses for auditors who wish to improve skills and develop areas of expertise, we are delighted to announce that the ‘How to Audit - Key Excipients’ course will be run by Peter Monger, a former MHRA inspector and extremely experienced auditor. The course is designed to provide practical help and guidance to those engaged in the auditing of excipients.

Course outline

New directives and expectations place increasing pressures on companies to audit the entire supply chain of starting materials including excipients.

Peter will be running this highly interactive course with the following objectives:

• Remind auditors of the key legislation and guidance around auditing excipients, GMP, IPEC, ISO 9000
• What is the role of EXCiPACT™?
• How to construct an audit plan or agenda that works
• Working through case studies and audit observations to discuss the severity ranking and references to support findings
• What to do when time on site is limited, shared or impossible

As with all ‘How to Audit’ courses there will be plenty of opportunity for questions and answers as well as sharing best practice with fellow auditors.

Spaces are limited on the ‘How to Audit’ courses to maintain the interactivity and to ensure your questions are answered, so early booking is recommended.

Venue

Manchester Marriott Victoria and Albert Hotel, Manchester, UK

The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.

Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.

Hotel Accommodation

• Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
• To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
• This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
• If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check-out.
• Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.

Venue Address and Contact Details

Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England

Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484

www.marriott.co.uk

Hotel Bookings

If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link

This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• Kevin McGlue
  CSci, CChem, MRSC. Director Global Quality Assurance, Colorcon.

Kevin is a former member of the Board of IPEC Europe. He was a member of the IPEC team that produced the 2001 revision of their Excipient GMP Guide, and was a member of the team responsible for the production of the current 2006 joint IPEC/PQG Excipient GMP Guide. He is also a past chair of the IPEC Europe GMP committee. Kevin has published numerous articles on Excipient GMP and is a regular speaker at seminars, conferences and training courses.

• 

  Mr Peter Monger
  Consultant
  CChem, FRSC

  • [email protected]
  • +44(0)1751 432999

What you've said

“Very interesting course delivered exceptionally well.”

Sajeevan Nirmalananthan, Biocompatibles, UK

“An interesting and informative course that provides a practical approach on the application of GMP and IPEC guidance when performing audits of excipient suppliers. The course was very interactive and the course tutors provided good examples and were extremely knowledgeable.”

Kirsteen Scott, Eisai Manufacturing, UK

“Lots of background information on the subject to digest. A good balanced view from both sides of the fence; both the regulator “and cheerleader” providing expectations of the auditor and auditee.”

Chris Unwin, Dr Reddys Laboratories (UK)

“Enjoyed the course - learnt loads!”

Caroline McLaughlan, Lofthouse of Fleetwood, UK