A-Z of Sterile Products Manufacture
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Sterile products manufacture represents the most hazardous activity (to the patient!) performed by pharmaceutical companies.
Dates:
Monday 31 March to Thursday 03 April 2025
Venue:
Renaissance Manchester City Centre Hotel, Manchester, UK
Cost:
£2550.00 excl. VAT or £3060.00 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
Sterile products manufacture represents the most hazardous activity (to the patient!) performed by pharmaceutical companies.
This is why it attracts so much regulatory scrutiny!
Recent regulations and guidelines from EU (Annex 1) and FDA ‘Sterile Drug Products Produced by Aseptic Processing’ are confusing to many and very difficult – and expensive – to comply with in full.
This course is designed to help you comply with these and other documents in a way that is…
- Practical
- Scientifically sound
- Cost-effective
This is by far the most popular of our courses – hundreds of people attend it every year, either through this residential course or via courses run in their companies – and delegate feedback is excellent!
What You Will Learn
- Current EU and FDA requirements for…
- design and qualification of cleanrooms
- environmental standards for controlled environments
- control of key utilities
- sterilisation processes
- process simulations (media fills)
- inspection and integrity testing
- How to satisfy these expectations in a practical way
- How to identify the root cause of any problem… and make the right risk-based decision!
- The influence of FDA’s ‘PAT’ initiative on aseptic processing
Course outline
Current Standards and Regulatory Requirements
- ISO 14644
- EU GMP Guide Annex 1
- FDA Guideline ‘Sterile Drug Products Produced by Aseptic Processing’
The Cleanroom
- Design
- Qualification
- HVAC systems and HEPA filter selection
Alternatives to Conventional Cleanrooms
Critical Utilities
- Steam – generation and quality expectations
- Water – generation, storage and control
Sterilisation Processes
- EU and US expectations for…
- steam sterilisation
- dry heat sterilisation
- filtration
- Other sterilisation processes
- ethylene oxide
- irradiation
- vaporised hydrogen peroxide
Environmental Monitoring
- Monitoring techniques
- Designing an effective monitoring programme
- Setting alert and action levels
- Data management
Process Simulations (Media Fills)
- Understanding the strengths and weaknesses of the media fill
- Current regulatory expectations
- How to demonstrate compliance
Disinfection Practices
- The importance of TACT
- Selection of disinfectants
- Validation of disinfection procedures
Container Integrity Testing and Particulate Inspection
- Methodologies
- Strengths and weaknesses
- Regulatory expectations
People Issues
- Gowning and gowning practices
- Qualification of cleanroom operators
- Good aseptic practices
Problem Solving and Troubleshooting Tools and Techniques
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 - 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 experts for this course are:
What you've said
“I am quite new to sterile manufacturing with little knowledge, so I found the course very relevant to my work. I have taken a lot of knowledge out of this course.”
Ross Pouncey, Reckitt Benckiser Healthcare, UK
“Coverage of all aspects at excellent level (for me). Buzz topics excellent (and answers provided to us). Trainers very committed and enthusiastic, very good training skills.”
Elma Loomans, MSD Global, The Netherlands
“Very good course, very experienced and motivating tutors! Got a good overview of the main aspects of sterile manufacturing; buzz group as practical work very helpful to apply.”
Christina Steinbronn, Ferring, Germany
“Excellent course, delivery by tutors was done in a very professional and delegate friendly environment. Course materials one of great value in future. Made great contacts on the course. Would highly recommend to colleagues - thanks.”
Patrick O’Connor, Schering-Plough, Republic of Ireland
“Excellent! Tutors brilliant on all aspects of the course. Content was extensive and explained accurately with ‘real-life’ examples.”
Rebecca Bent, Eli Lilly & Co Ltd, UK
“The course was excellent; it introduced all subjects at a basic level and then progressed to an advance level. The tutors were very knowledgeable and extremely helpful. The notes and presentation was excellent.”
Julie Tynan, Genzyme Ireland Ltd, Republic of Ireland
“Integration with tutors and delegates, allowed discussion of real-life issues/concerns. Course covered a lot of subjects in a good depth.”
Paul Fullerton, Aptuit Ltd, UK
An NSF International Company 
