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.
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.