We will be continuing to support a number of conferences and training events in 2018. These events help us to keep up to date with the changing requirements of pharmaceutical regulation, such as the long-awaited revision to EU GMP Annex 1. They also provide us with the ideal opportunity to discuss the individual challenges delegates face and to advise them on the most suitable solutions we can provide for their specific requirements.
Here are the details of the of 2018 events we are scheduled to attend so far:
Cleanroom Technology Conference
16th and 17th May 2018 – National Conference Centre, Birmingham
The Cleanroom Technology Conference is designed to highlight best practice and regulations affecting both cleanroom design and cleanroom operation across various sectors for those working in controlled environments and cleanrooms. The conference will feature case studies, panel discussions and papers from leading industry experts across two days, covering topics including Regulations & Standards (ISO 14644 & ISO 14698), Microbiology, Containment, Operation and Validation, Consumables, Clothing & PPE, Cleanroom Design, Safe Utility Usage.
Parenteral Drug Association (PDA) – Annex 1
17th May 2018 - Crowne Plaza Dublin - Blanchardstown, Dublin, Ireland
Revision of the EU GMP Guideline
The long-awaited draft of the revised Annex 1 has finally been released for discussion! The document’s content has increased significantly and the industry is eager to see which formerly missing subjects have now been included. Possible clarification on various vague topics is also highly anticipated.
The conference has been set up by PDA Europe to cover the impact of these changes on the industry and on manufacturers.
PHSS – Annual Challenges in Sterile Product Manufacture
7th June 2018 - The Mere Hotel, Knutsford, Cheshire
The 2018 annual PHSS Challenges in sterile product manufacturing conference will consider the impact of EU GMP Annex 1 revision and GMP guidance where clarity is required.
Following the consultation process on revision of Annex 1, it is clear, supportive guidance in GMP will become even more important as new products, advanced technologies and new practices are developed and implemented using a risk based approach.
The balance between prescriptive GMP and QRM (Quality Risk Management) principles will be
considered together with a key requirement of the revised Annex 1 to prepare a Contamination
control strategy. Presentations will include examples of GMP principles and QRM working
together.
Aseptic Preparation and Dispensing of Medicines (APDM)
3rd – 4th July 2019 - Leeds Trinity University
This course is organised by the NHS, Technical Specialists Education and Training (TSET) Group and the University of Leeds. It is designed to meet the needs of pharmacy staff who work in licensed and unlicensed aseptic units. It covers the principles and practice of asepsis and provides an update on knowledge of standards, practices and quality assurance arrangements relating to the aseptic preparation and dispensing of medicines.
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