As always, Lachman Consultants looks to provide excellence in all phases of serving our clients’ needs, so we paid close attention to the various speakers, panels and general goings-on at the 2019 ISPE Europe meeting to take the pulse of the industry. We also spoke to many of the show’s attendees, and the takeaways from our many observations and conversations covered a variety of topics. “Digital” was a word used in many discussions. We heard talk of what the facility of the future might look like – a “digital plant” with seamless systems connectivity – and overcoming the many challenges to achieve it. Cost efficiency was also top of mind, as was the ability of organizations to become more agile while continuing to maintain quality. Last, but not least, was the issue of staffing and the shortage of experienced, capable candidates.
At the ISPE Europe conference, Lachman also conducted a survey of attendees, asking the question, “What’s the number one thing on the mind of your organization right now?” If there’s one thing that stood out, it was the wide range of responses, rather than a single, dominant answer. Respondent feedback covered operational topics like validation, data integrity, and automation. Organizational growth was another topic, as was human resources with a focus on staffing, training, and company culture. People were also thinking about Pharma 4.0 and its short- and long-term impact on their organizations. We also received some comments on Annex 11/Part 11 and their requirements for technical and procedural controls.