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Regulatory Affairs for QA: Variations

NSF International, Pharmaceutical Services
Course summary
1 day
700 GBP excl. VAT
English
Full time
Online courses
Next available date: 01/10/2020 08:45 - Online courses

Course description

Regulatory Affairs for QA: Variations

An interactive pharmaceutical 'refresher' workshop on the variations process requirements and categorisation in EU and US that is specifically designed for QA Professionals.

*All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Suitability - Who should attend?

An interactive refresher on the variations process requirements and categorization in EU and USA that is specifically designed for QA professionals.

This workshop includes real examples of regulatory procedures and data requirements for variations to EU MAs/and post-approval changes to US NDA/ANDA/BLA submissions.

This workshop will explore:

  • Regulatory agency expectations on the data that should be included in variation
  • The categorization of post-approval changes; e.g. 1A, 1B, Type 2 in EU and CBE0, CBE30 or prior approval in USA
  • The need for the QP/QA to be kept informed regarding post-approval changes via an effective change control process
  • New/emerging expectations arising from ICH Q12

Training Course Content

By the End of This Workshop, You Will Improve/Expand…

  • Your awareness and knowledge of the latest regulatory procedures for post-approval changes
  • Your knowledge on how EU and USA regulatory procedures work
  • Your ability to communicate with your regulatory support functions

Why choose NSF International, Pharmaceutical Services

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert pharmaceutical training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Expenses

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...


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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

Reviews

Average rating 5

Based on 1 reviews

A. Cini
(5)
Excellent course - delivery was clear and easy to understand and I am more confident about variations roles
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Course rating
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