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Date:
10th October 2019

Venue:
De Montil
Moortelstraat 8,
1790 Affligem-Essene

Price

850 euros (VAPI-UPIP Member)
955 euros (non-Member, includes membership)

Registration has to be confirmed before 05th October 2019
Number of participants: max 40
A training certificate is provided to all participants at the end of the training.

Who should attend this training?

Members of Quality Assurance, Production and Regulatory Departments in Pharmaceutical and Medical Device Industries
Qualified Persons and GDP Responsible Persons

NSF Training on Pharmaceutical Legislation and Guidance Update

Registration for to NSF Training 10th Oct 2019 (PDF)

Register on-line here

The program of this training day session:

08.30 – 09.00 Course Registration and Welcome
09.00 – 09.10 Session 1: Introduction and Objectives
09.10 – 10.10 Session 2: Changes to EU Legislation and Guidance

  • The CT Regulation 536/2014
  • GMP Legislative Changes (Human & new Veterinary Legislation)
  • Medical Devices Regulations
  • EU-USA MRA

10.10 – 10.30 Refreshment Break

10.30 – 11.15 Session 3: Changes to EU GMP Guidance

  • EMA Q&A on Health Based Exposure Levels (HBELs)
  • Revision of Annexes 1, 2, 13 and 17
  • New Annex 21

11.15 – 12.00 Session 4: The Potential Impacts of Brexit on QPs in Europe
12.00 – 13.00 Lunch Break
13.00 – 13.45 Session 5: Teamwork

  • What contingency plans should be put in place to prepare for EU changes and Brexit?

13.45 – 14.30 Session 6: ICH Changes

ICH organization; new members and observers

ICH Q3D

ICH Q11 Q&A

ICH Q12

Revision of Q2 and new Q13 & Q14

14.30 – 14.45 Refreshment Break

14.45 – 15.30 Session 7: Changes to USA Legislation and Guidance

  • PAG Initiative and Concept of Operations
  • New Final and Draft Guidance for Industry
  • Combination Products
  • Quality Agreements
  • Quality Metrics

15.30 – 16.00 Session 8: Final Questions and Answers

16.00 Conclusion and Course Close

Speaker:

 Gough

Dr Peter H. Gough
Hon. DSc, MSc, CSci, CChem, FRSC, FCQI, CQP
Executive Director at NSF Health Sciences

  • Recognized Areas of Expertise
  • Pharmaceutical Laws and Guidance
  • The role and responsibilities of the European Qualified Person (QP)
  • Pharmaceutical analysis and testing; particularly Good Control Laboratory Practice (GCLP) and the handling of out of specification (OOS) results
  • The design and application of pharmaceutical quality management systems
  • Quality risk management and its application within the quality by design (QbD) framework
  • Statistical process control and the integration of statistical thinking within the quality management system
  • Manufacture and control of oral solid dosage forms
  • Hosting and Preparing for Regulatory Authority GMP Inspections (EU & FDA)
 

 

 

UPIP-VAPI Timeline 2019


 TIMELINE 2019 UPIPVAPI WEB2


 

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