Video: Get you company into the quality mindset

The UK’s withdrawal from the European Union has meant the pharmaceutical industry has had to adapt to some monumental changes in terms of research, regulatory affairs, and trade. In this CPHI Webinar, three industry experts discussed what the future may hold for UK pharma in a post-Brexit world

This edition of the Journal focuses on adaptability. Martin Lush highlights the importance of training and education to improve your business and John Johnson explains how to manage the risks associated with outsourcing. We take an in-depth look at the growth of biopharma and med tech in Ireland and how NSF supports this. We also cover the FDA’s Sentinel Initiative and its five-year strategic plan as well as the latest changes in the EU MDR.

The theme of this Journal is change or suffer the consequences. An article on managing change examines different types of change and considerations for navigating each type, and transformational change case studies provide insightful advice for you and your organisation. It also includes a tech talk article on continued process verification, and articles that challenge the need for so many rules and regulations.

This edition of the Journal includes insight from Martin Lush on the future of the pharmaceutical industry, an article on data integrity issues drawing on years of research and a look into the hierarchy for CAPA effectiveness. We also cover the latest regulatory updates, information on NSF’s new eLearning program and all the latest NSF news.

You are only as good as your people. We offer education programs that will change behaviors, improve performance and "future proof" your organization. Any of our public courses can be tailored and run on-site. Whether you are looking to send one of your people to a public course for career progression (including becoming a Qualified Person), to train many employees economically online, to train a group of staff in house in changes in procedures and regulations, or to bring about culture change within an entire organization, we have the skills and programs to meet your needs. Education offered annually include: Good Manufacturing Practice, including clinical trials Regulatory issues and regulatory affairs Auditing and self-inspections (A CQI and IRCA certified course) Sterile products manufacture Quality risk management Human error prevention Changing GMP behaviors Data integrity Process validation Deviation report corrective and preventative action (CAPA) We also work alongside the University of Strathclyde to provide a Royal Society of Chemistry Approved Qualified Person training program.

David Waddington looks at the most common European and U.S. FDA regulatory findings related to basic cleaning issues including cross contamination and approaches to cleaning validation. He also highlights key changes in GMP guidance and discusses QP considerations such as the appropriate use of quality risk management and HBEL assessments.

NSF/ANSI 455 defines the audit process and certification body requirements for OTC drugs’ GMP compliance. It was developed to establish a level playing field for certification bodies, reduce the audit burden on OTC manufacturers and ultimately ensure a high level of quality, reliability and trust in the OTC products supply chain. In this webinar, Jim Morris describes the standard development process, key stakeholders, structure and key elements of the NSF/ANSI 455 standard.