GMP for Biological and Biotechnology Products
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The development of new biopharmaceuticals and biotechnology products promises to bring about a revolution in global healthcare.
Dates:
Tuesday 03 to Thursday 05 February 2026
Venue:
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
Cost:
£1910.00 excl. VAT or £2292.00 incl. VAT
Discounts: We offer a 10% discount to 1st delegate bookings that are paid at least 12 weeks prior to the course start date. We also offer a 20% discount for 2nd delegate bookings from the same company and site and a 50% discount for 3rd delegate bookings from the same company and site.
Type: Pharmaceutical
About this course
The development of new biopharmaceuticals and biotechnology products promises to bring about a revolution in global healthcare. However, the manufacture and control of such products brings with it special concerns and challenges which, if inadequately addressed, could jeopardise product quality and patient safety.
If companies are to be successful in this highly important arena, it is essential that staff at all levels clearly understand…
- The risks and challenges associated with biopharmaceuticals manufacture and control
- The rapidly changing international regulatory demands and expectations for these products
- How these requirements can be translated into a practical, effective and cost-effective quality management system
All these issues and more will be addressed in this introductory three-day training course.
What You Will Learn
- Current EU and US regulations and expectations for the manufacture of biopharmaceuticals for commercial and clinical trial use
- Key GMP compliance issues for the different stages of the manufacturing process…
- cultivation
- QC
- downstream processing
- shipping
- fill and finish
- key issues of importance to the Qualified Person
This course is a highly interactive, tailored course that is ideal for experienced staff entering the field of Biological and Biotech products for the first time, or as a timely refresher for Quality and Operations professionals already engaged in this important segment of the pharma/biotech industry.
Course outline
Regulatory Issues
- US and EU regulatory frameworks for biopharmaceuticals
- Current GMP regulations, guidelines and ‘hot topics’
Premises and Plant
- Fundamental design concepts and segregation
- Specific requirements for multiproduct facilities
- Environmental classification and monitoring
Starting Materials
- Sampling and testing requirements
- Supplier certification
- GMP requirements for cell banks/seed lots
Specific GMP and Validation Requirements for…
- Cultivation and harvest
- Purification
- Virus and DNA clearance
- Cleaning
- Equipment sterilisation and decontamination
- Shipping
Quality Control Aspects
- Specific requirements for bioassays
- Control of standards and reference materials
- Handling OOS and OOT results
Quality Management
- Essential elements of a quality management system for biopharmaceuticals
- Handling deviations and CAPAs
- Change control
Key Issues for the Qualified Person
- The technical agreement
- Audit expectations
- Involvement in deviations
- The batch review process
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:
What you've said
“Very good course, with just the right level of technical detail.”
Stephen Ferguson, Teva UK, UK
“Excellent course. Broad content, technical and general GMP concept reminders.”
Chris Skiller, Sanofi-Aventis Pharma, UK
“Well run, good hand-outs, good pace.”
Samantha Carmichael, NHS Greater Glasgow & Clyde, UK
“Good course material and up-to-date information. Good summary review.”
On Kan, Adaptimmune, UK
“Very useful for me as a scientist entering the development field.”
Luca Melchiori, Adaptimmune, UK
“Good overview. Very good speakers. Thank you!”
Martin Tribus, Sandoz, Austria
“Enjoyed the opportunity to learn from highly knowledgeable tutors.”
Michael Edwards, GlaxoSmithKline, UK
“I learned a lot from the Buzz Groups. Thank you!”
Matthijs Koorevaar, Crucell, The Netherlands
“An excellent week.”
Martine Powell, Genzyme, UK
“Excellent overview of production of biotech products!”
Sandra Grote Beverborg, Organon, The Netherlands
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