How to Audit Sterile Products Manufacture

About this course

The manufacture of sterile products is perhaps the most hazardous of all pharmaceutical production activities – failures can and sometimes do result in patient harm and death. That is why auditing of sterile filling operations is essential and why it is important that the auditor has the right knowledge and experience to conduct the audit with skill and professionalism.

This short, focused course is designed to help auditors with little or no direct experience of auditing sterile filling operations to know where the risks lie, what questions to ask and how to assess whether or not processes are under control.

Course outline

• What makes sterile products special
• An overview of relevant GMP guidance
• The quality critical steps in sterile filling and how to ensure these are under control
• How to plan an audit of sterile filling
• How to assess the effectiveness of environmental monitoring programmes
• The key questions to ask
• What answers to expect!

Venue

Renaissance Manchester City Centre Hotel, Manchester, UK

Located in one of the most exciting cities in UK, the 4 star Renaissance Manchester Hotel is at the heart of Manchester’s entertainment quarter. The hotel features one of the largest conference venues in the city which also provides wireless internet access.

The hotel offers spacious bedrooms with air conditioning, lounge area, excellent workspace and WIFI access.

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

Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester
M3 2EQ
England

Tel: +44 (0) 1618 316 000
Fax: +44 (0) 1618 353 077

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 expert for this course is:

• 

  Mr Darren Jones
  Consultant
  BSc (Hons)

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

What you've said

“Good level of information with expert guidelines for good auditing practice.”

Adam Elliott CP Pharmaceuticals (Wockhardt), UK

“This course has reaffirmed knowledge that I already had about sterile manufacturing and has given me confidence to be able to conduct relevant and effective audits.”

Sarah Kelly, CP Pharmaceuticals (Wockhardt), UK

“Excellent course, good balance of lectures and group based tasks.”

Stephen Weetman, CP Pharmaceuticals (Wockhardt), UK

“Good, precise summary of important innovations for sterile auditing.”

James McCraken, Amdipharm Mercury, UK

“Excellent insight into auditing sterile operations, this has increased my confidence greatly.”

Waqar Mirza Pharmaserve, UK

“Gave a good brush up for auditing sterile manufacturers, without using more than a day.”

Henric Larsson, Takeda Pharma, Denmark