Presented by
Management Forum
The Regulatory Requirements on Nitrosamines in the Pharmaceutical Industry Training Course
In this webinar, we will discuss the major requirements and strategies for nitrosamines, a hot topic that is on the forefront of many company's minds.
12-13 May 2025
+ 13-14 October 2025 »
from £649
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
Course overview
Nitrosamine regulations are the most impactful change to our industry in recent years, affecting 30% of current and new products, including generics. Regulatory expectations have changed frequently and vary globally. In this webinar, we will discuss the major requirements and strategies. Those new to the subject and those growing their nitrosamine team will find value in seeing the entire picture. Experienced SMEs will receive detailed instructions for common pain points, like risk assessments.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of attending
- Enhance your understanding of current regulatory framework and recent changes
- See the full scope of work for your team members to understand how their part fits with the whole
- Learn best practices for risk assessments
- Inform next steps when your product is near or above regulatory limits through remediation, control strategies, and new research
- Example products guide the way to practical understanding
Who should attend?
This course will benefit nitrosamine decision makers and those who can benefit from a broader understanding of the full picture of nitrosamines in regulatory affairs, sales, quality, and analytical departments.
This course will cover:
History and background
Classes of nitrosamines
Regulatory update
Team Building
Risk assessments
At risk structures
Limit determination
Nitrosation Assay Procedure (NAP) test
Analytical instruments and methods
Control strategy
Remediation
Post approval changes
Where are we going? Future state and unanswered questions
Jason Brown
Adare Pharma Solutions
Jason Brown brings a wealth of knowledge and practical experience to his role as Senior Analytical Sciences Manager at Adare Pharma Solutions, where he serves as the global nitrosamine subject matter expert. He has led Adare’s innovative approaches to understanding nitrosamine formation, measurement, and mitigation to ensure regulatory compliance internally and for our customers. Jason has led numerous dialogues on the subject of nitrosamines through panel discussions, webinars, posters, articles, and regular contributions to the USP Nitrosamine Forum. Jason has a BS in Chemistry from George Fox University.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
12-13 May 2025
Live online
13:00-16:00 UK (London) (UTC+01)
14:00-17:00 Paris (UTC+02)
08:00-11:00 New York (UTC-04)
Course code 15454
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 07 Apr
- 2 half days of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
13-14 October 2025
Live online
13:00-16:00 UK (London) (UTC+01)
14:00-17:00 Paris (UTC+02)
08:00-11:00 New York (UTC-04)
Course code 15455
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 08 Sep
- 2 half days of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Portugal
- Laboratory Medinfar
Run The Regulatory Requirements on Nitrosamines in the Pharmaceutical Industry Live online for your team
1 day
Typical duration
Pricing from:
- GBP 500
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
