How to Audit - Bulk Biotech Operations
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Improving Your Auditing Skills, The How To Audit Series
Dates:
Friday 21 February 2026
Venue:
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
Cost:
£735.00 excl. VAT or £882.00 incl. VAT
(2nd delegate bookings from the same company and same site will receive a 20% discount on the course fee)
Type: Pharmaceutical
About this course
This course is designed to give existing auditors, who have no ‘bio’ background, sufficient exposure to some of the specific issues involved in biologics and biotech processing to allow them to approach a biologics/biotech audit with confidence. GMP requirements of both EMA and FDA (CBER) are addressed. The course is ideal for delegates who have either previously attended NSF-DBA’s IRCA certified Pharmaceutical Quality Management Systems Auditor/Lead Auditor course, or who already have a good understanding of the basic principles and practices of auditing and wish to expand their technical understanding to biologics/biotech GMPs. The course can also contribute to registered auditors’ and lead auditors’ professional requirement for continuing professional development (CPD).
This course will also be ideal for manufacturing and quality personnel already working in a biologics/biotech facility who wish to undertake effective self-inspection.
What You Will Learn
- How to develop an audit aide-mémoire for risk-based auditing of bulk bio manufacturing
- A structured approach to an audit that will address both EMA and FDA expectations
- Reasonable expectations for environmental and in-process monitoring for bio facilities
- Risk-based prioritisation of activities to be audited when time presses (doesn’t it always!)
- Practice, in a non-threatening situation, in classification of bio facility audit observations
Course outline
- Developing an aide-mémoire for audit of a facility manufacturing bulk biologic and biotech APIs
- Risk-based planning of the audit
- Interpreting and auditing against current EudraLex Volume 4 Annex 2 and FDA’s Compliance Program Guidance Manual (CBER 7345.848) requirements
- Key quality systems for biologics and biotech bulk manufacture, including:
- Biological raw materials sourcing and control
- Technology transfer and process validation for biological and biotech API processes
- Cleaning validation for biological and biotech API processes
- Critical review of deviation management in a biologics/biotech context
- Interpreting and auditing against regulatory requirements and industry best practice in respect of:
- Facility, utility and environmental monitoring and control
- In-process monitoring and control
- Assessing performance in respect of:
- Bioburden management and control
- Cross-contamination avoidance
- Control of ‘live biologics’ operations
- Appreciating the limitations of bioassays in control of bulk biologics manufacture
- Review of biologics and biotech process documentation
- Classifying biologics and biotech audit observations
Why not bring your problems for discussion?
The course offers an ideal opportunity to speak to an experienced tutor and to delegates who are in similar roles. Our courses are planned to inform you and also to enable you to gain answers to your specific queries via debate, group work sessions and a panel discussion.
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 - link to be confirmed shortly”
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:
What you've said
“I liked the discussions and that we were able to ask specific questions.”
Henric Larsson, Takeda Pharma, Denmark
An NSF International Company 
