Why has this Special Interest Group been formed?
Cybersecurity has become more critical in today’s GxP environment. The speed and complexity of growth within information technology that supports business and GxP operations has introduced greater cybersecurity risks. The validation process has to ensure the effective incorporation of important cybersecurity controls and methodologies.
What are the key drivers/objectives of the Special Interest Group?
The importance of including key concepts of cybersecurity risk management in GAMP® 5 and Data Integrity models are the key drives and objectives. Cybersecurity requirements should be part of the specification process, included in the risk assessment, and there should be verification that the required controls are operating effectively. We want to educate ISPE members and the industry on these concepts.
Cybersecurity has become more critical in today’s GxP environment.
What regions are represented by Special Interest Group members?
The team includes owner companies, consultants, and organizations across the world from the US, Europe, and Asia.
What are the hot topics being addressed?
Topics include identifying relevant regulatory cybersecurity requirements; identifying regulatory expectations; how to manage cybersecurity for infrastructure and GxP regulated systems by using existing good cybersecurity practices; and incorporating cybersecurity into the GAMP® 5 framework of specification, risk assessment process, and verification of appropriate controls.
What are the main challenges with these topics?
The main challenge is creating guidelines that are easy to understand and adopt.
What is the expected output of the Special Interest Group, and what is the time frame?
The output will include ISPE education sessions (for example, at the ISPE Annual Meeting & Expo and local ISPE Chapter and Affiliate meetings) and developing ideas and concepts for articles, papers, and presentations. The time frame is late 2020 through early 2021. The Special Interest Group is established, and the plan is to define terms, technology boundaries, and an initial set of guidance.
Welcome The Bridge, ISPE Women in Pharma® Newsletter
ISPE Women in Pharma® (WIP) has launched a monthly newsletter devoted to Women in Pharma® and its many activities and initiatives. The Bridge began publishing in March. It was developed to open the lines of communication among ISPE Chapter and Affiliate Women in Pharma® leaders, provide news, share ideas and best practices, and ensure Women in Pharma® leaders are kept informed of helpful information as well as updates in policies and procedures.
The May issue (the most recent issue at Pharmaceutical Engineering® press time) featured articles on the “new normal” of life in the pandemic world, a new lead for the Women in Pharma® Mentor Circle Program, and updates on Women in Pharma® activities from a number of ISPE Women in Pharma® Chapters and Affiliates.
The Bridge Newsletter
ISPE D/A/CH YPs & Students Face-to-Face Meeting in February