Deviation and CAPA Systems - Best Practices
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How good is your Deviation and CAPA system… or are you at RISK?
Dates:
Monday 28 to Tuesday 29 April 2025
Venue:
Renaissance Manchester City Centre Hotel, Manchester, UK
Cost:
£1470.00 excl. VAT or £1764.00 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
How good is your Deviation and CAPA system… or are you at RISK?
- Can you guarantee your deviations will never happen again, or are costly repeat incidents common?
- Do you use every incident as a learning opportunity for ‘Continuous Quality Improvement’, or are deviations closed to get the batch released?
- Do you really identify root cause, or just conclude ‘Human Error’ for most incidents?
- Does your system efficiently ‘triage’ or prioritise incidents based on risk, or do you treat every incident the same… which is costly and dangerous?!
- Can you report, investigate and resolve deviation incidents in hours, or only within the unacceptably long ‘30 days’?
- Years after the incident, can you accurately reconstruct the history of the event from the report, or are you left guessing in front of a frustrated inspector?
Your Deviation and CAPA system is a crucial part of your Quality System. It should protect your patients against poor quality medicines and drive Continuous Quality Improvement by stopping inefficient, wasteful and often dangerous practices. This course is not just about how to conduct a root cause investigation. It is much, much more.
What You Will Learn
- How to use your deviations to drive down costs and reduce complexity by removing non- value-adding activities and driving forward Continuous Quality Improvement
- How to make ‘repeat’ incidents a thing of the past!
- How to apply structured, risk-based decision making tools and techniques to ensure that every incident is investigated to root cause in a consistent and thorough manner
- How to report, investigate and resolve incidents within hours, not days or weeks
- How to ‘triage’ or prioritise deviations so that you focus your time and resources on what really matters
- How to make sure that your deviation reports provide an accurate history of events!!
Course outline
The What, How and When of Deviation Reporting
- How to ‘map’ a deviation incident
- How to use risk assessment to classify deviations
- How to collect and analyse information efficiently
- Use of practical problem solving skills, including process flow diagrams, force field and pareto analysis
- Techniques to identify root cause
Corrective and Preventative Action (CAPA)
- How to identify CAPAs that work
- How to implement CAPAs successfully and on time!
Deviation Management: Best Industry and Regulatory Practices
- How to prevent excessive reporting of deviations
- How to write deviation reports to satisfy the needs of the QP, senior management and the regulator
- How to move from ‘fire fighting’ to genuine quality improvement
Discussions and Working Groups
A significant proportion of course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
There will also be a practical demonstration of orbital welding.
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
“Very good and comprehensive course.”
Christina Huf, Shionogi Ireland, Republic of Ireland
“Generally very good, tutors well informed and experienced.”
Sean Ring, Nova Laboratories , UK
“Good group sessions to exchange practices, very useful. Very lively course. Overall very good.”
Sebastien Duquesne, Celgene International, Switzerland
“Excellent course – thoroughly enjoyed it.”
Claire Anthony, Quantum Specials, UK
“Useful ideas for best practice in management of deviations and CAPA and measuring effectiveness and trending.”
Cathy Brown, Bard Pharmaceuticals, UK
An NSF International Company 
