17th & 18th MARCH 2014 – Kane Edgeworth (Managing Director, Biomap Ltd) joined course Chairman Dr Afshin Hosseiny (Managing Director, Tabriz Consulting) and Andrew Portess (Quality and Regulatory Affairs Manager, UDG).
The course was designed to bring delegates up-to-date with the current regulatory thinking and standards for Good Distribution Practice (GDP). Providing practical guidance on how to perform gap analysis, prepare plans for implementing systems and procedures to bring organisations into compliance with the new regulations.
Speakers:
Dr Afshin Hosseiny– Independent Quality Management Consultant, Tabriz Consulting, UK
Andrew Portess– Quality and Regulatory Affairs Manager, UDG, UK
Kane Edgeworth– Director, Biomap Ltd, UK
Further details:
6th & 7th MARCH 2014 – Kane Edgeworth (Biomap Ltd, UK) joined speakers Dr Afshin Hosseiny (Tabriz Consulting Ltd, UK), Ian Holloway (MHRA, UK) and Dr Andreas Konig (Aenova Holding, Germany).
During the course experienced speakers shared expert knowledge about relevant aspects regarding GMP and GDP requirements and current developments in storage, transportation and Cold Chain management. The course was designed to allow delegates to efficiently implement the requirements. Kane Edgeworth gave a talk on Temperature Mapping (Warehouse, Cold Storage & Vehicle Studies) including protocol preparation, consideration of seasonal variations & impact tests as well as results and final reporting.
Speakers:
Dr Afshin Hosseiny– Tabriz Consulting Limited, UK
Ian Holloway– MHRA, UK
Kane Edgeworth– Biomap Ltd, UK
Dr Andreas Konig– Aenova Holding GmbH, Germany
Further details:
The Pharmaceutical Quality Group (PQG) issued a monograph on Pharmaceutical Distribution in 1997 and initiated planning to revise this in line with the new EU GDP regulatory guideline (a final revised version was issued in March 2013 with an effective date of 8 September 2013). Whilst undertaking this planning it was identified that the European Compliance Academy (ECA) was also planning to produce some guidance in response to requests from members. The two organisations therefore decided to join forces and set up a joint steering committee led by Afshin Hosseiny with Philip Butson and Ashley McCraight. Kane Edgeworth (Director, Biomap Ltd) was invited to participate in the working group and contributed to Chapter 9 Transportation.
Interpretation of Chapters 1 & 9 is now available:
http://www.good-distribution-practice-group.org/gdp_news_3973_7940,S-GDP.html
LRQA (Lloyd’s Register Quality Assurance) has issued Biomap Ltd with ISO 9001: 2008 Certificate of Approval. ISO 9001:2008 sets out the criteria for a quality management system and is implemented by over one million companies and organizations in over 170 countries.
The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management and the process approach to continual improvement. Using ISO 9001:2008 helps Bioamp Ltd ensure that it’s customers get consistent, good quality products and services as well as giving the peace of mind that a 9 monthly independent audit is carried out by LRQA (world leading, independent provider of Business Assurance services including management system certification, validation, verification and training to bespoke and international standards and schemes)