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NEW DATE for Batch Record Review & Certification by the Qualified Person

Wednesday, November 01, 2023, 5:30 pm-Friday, November 03, 2023, 8:30 pm

£30.00 excluding VAT

If you were booked to attend on the 4th October and are unable to attend on the 1st November please email  admin@pqg.org

17:00 Registration opens
17:30 Food
17:45 Meeting opens
20:30 Meeting close

The event aims to provide a baseline understanding and application of the requirements related to batch record review process, critical checks, risks and certification by a Qualified Person for Clinical, Commercial and ATMPs dosage forms. This evening and related materials are aimed at the Junior Quality Professional, who would like to improve their personal knowledge or move into batch record review and product disposition, trainee Qualified Persons etc.

The evening will be led by introductory education materials from Dark Horse Consulting representatives Liam Breen (Sr Consultant), Lyndsey Atkins (Sr Consultant), David Jasek (Principal) and supported by DHC eligible QPs Ian Pardo and Stephan Croft. The format of the evening will be a mixture of PowerPoint presentation, break-out challenge groups & scenarios with feedback sessions and Q&A.

To facilitate the interactive nature of the evening, the number of delegates will be limited, so book today to secure your place. A certificate of attendance will be issued by the PQG for your CPD records.

The session will include the following agenda items:-

  • Introduction
  • Legislative review (Including global equivalent guidance or legislation from a number of major territories)
  • Annex 16 review and application
  • Annex 13 review and application to QP certification
  • Eudralex Volume 4 Part 4 ATMP review and application to QP certification
  • Breakout Groups and examples
  • Conclusion
  • Q&A

On booking this meeting you will receive a confirmation of your place and a VAT receipt.

The cost of the event includes light refreshment of sandwiches (with vegetarian options) and tea/coffee.

The Woburn Suite 

From Senate House Reception, go straight ahead, passing through the Crush Hall. Turn right at the Café and the Woburn Suite is on the left.

If you have any questions e-mail admin@pqg.org

Details

Start:
Wednesday, November 01, 2023, 5:30 pm
End:
Friday, November 03, 2023, 8:30 pm
Cost:
£30.00

Organiser

Sarah Powell
Email
admin@pqg.org

Venue

The Woburn Suite, Senate House, University of London
Malet Street
London, WC1E 7HU United Kingdom
+ Google Map

Tickets

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