Presenter at Tema Renrum 2024

Di Morris will give 2 presentations during Tema Renrum 2024, please read more about her presentations below

Di Morris

Pharmaceutical & Healthcare Sciences Society (PHSS) and PNR Pharma Limited (UK)

Di Morris is a chemist and microbiologist and a Qualified Person who has worked in the pharmaceutical industry for over 40 years including working for the UK MHRA as a Senior Medicines Inspector. Di has worked in the areas of Quality Control, Quality Assurance and Regulatory Affairs.

Di is Co-Deputy Chair of the not-for profit UK organisation PHSS and co lead on the sterile and contamination control strategy special interest groups. Di has worked with a wide range of dosage forms including sterile products, biological, and non-sterile products (solids, liquids and creams etc).

Di now works as Qualified Person and Quality Compliance Advisor for PNR Pharma Limited.

SEE ALL PRESENTATIONS REGISTRATION
Presentation 1 (2) from Di Morris

Fundamentals of Contamination Control – CCS

The Contamination Control Strategy (CCS) is an important topic that Di has been talking about since 2014.  There are different ways to generate a CCS that Di will go through during her presentation.

The presentation cover:

  • What format to use
  • What should it include
  • Links to ICH Q9 (R1)
  • How to gather the information
Presentation 2 (2) from Di Morris

Preparing for an Inspection

This second presentation will be linked to the first of Di’s presentation covering fundamentals of Fundamentals of Contamination Control – CCS .

“You should always be inspection ready”! 

In this presentation Di will cover the areas that will always be inspected or audited by customer.

The presentation cover: 

  • Process to follow
  • Who is involved
  • Metrics
  • Prepare your operational staff.
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