From The Editor | September 15, 2015

Key Trends, Cross Pollination Drive Pharma EXPO

ken congdon

By Ken Congdon

Key Trends, Cross Pollination Drive Pharma EXPO

Pharma EXPO is right around the corner. The event will be collocated with PACK EXPO at the end of the month (Sept. 28-30) at the Las Vegas Convention Center. This collaborative effort between PMMI — The Association for Packaging & Processing Technologies and ISPE (The International Society for Pharmaceutical Engineering) promises to showcase industry-leading education and some of the latest technologies impacting pharmaceutical manufacturing, processing, packaging, and supply chains.

There are several reasons why pharmaceutical manufacturing professionals should attend Pharma EXPO, but perhaps the most compelling is how well the conference program, organized by ISPE, aligns with the trends that are currently having a profound impact on our industry. The following are three key trends that helped shape the educational sessions on tap at Pharma EXPO.

  1. Cross Contamination Containment — On March 1, 2015, the EU adopted new GMP regulations that address cross contamination. Specifically, Chapters 3 and 5 of Volume 4 of the Eudralex have been updated to provide improved guidance on the prevention of cross contamination. These updates have been expected for some time, yet many pharmaceutical manufacturers are still trying to make the adjustments necessary to comply with these changes.

In response, Pharma EXPO has included two sessions on cross contamination in its conference program. The first, titled Microbial Contamination: An Audit Approach To Address Contamination In Process Equipment is part of Monday’s Manufacturing Operations track. This session will focus on critical elements that have been effective in troubleshooting and correcting microbial contamination at various sites. The second is titled Managing Risk Of Cross Contamination For Multiple Product Facilities: Dedication, Segregation, Or Other?  This session is part of Tuesday’s Compliance Trends track and will address the application of risk methods including Risk MaPP; Eudralex EU Volume 4 requirements for segregation; and dedicated equipment, process rooms, and facilities in an effort to prevent cross contamination.

“These two sessions complement each other nicely,” says Jan Baurley, Consultant of Global Quality Systems at Eli Lilly and a member of the Pharma EXPO Conference Education Planning Committee. “One focuses on managing cross contamination from a facility perspective, while the other focuses on process. An attendee could gain a well-rounded view of cross contamination challenges and best practices by attending this combination of seminars.”    

  1. Root Cause Analysis — It used to be that pharmaceutical inspectors simply wanted to know that you performed a risk assessment. Proof of completion isn’t enough anymore. Nowadays, inspectors want to examine the risk assessment for definitions, deviations, and outcomes. This review ultimately has a single goal — to identify the root cause of an event. Pharma EXPO will tackle this topic in several sessions, most notably in Finding The Root Cause: Utilizing Risk Management To Develop A More Robust Incident Investigation Model.
  2. CMO Selection — Determining when to keep something in-house and when to partner with a CMO is a huge consideration for many pharmaceutical manufacturers today. Pharma EXPO provides guidance in this area with the session Outsourcing Dilemma: Find The Right CMO To Minimize The Risk And Maximize The Quality Of Your Brand

This presentation will provide attendees with leading questions to ask of CMO suppliers that can be used in a risk assessment. A general risk assessment exercise format will also be presented, and a small group exercise will be used to evaluate a list of hypothetical CMOs for a hypothetical project.

Cross Pollination Creates New Learning Opportunities

While Pharma EXPO offers a ton of industry-specific educational opportunities, the sheer fact that the event is collocated with PACK EXPO provides pharmaceutical attendees with a unique forum to learn how other industries (e.g. food and beverage, chemical, consumer goods, etc.) address shared manufacturing, processing, packaging, and supply chain challenges. “No industry works in a vacuum and the Pharma EXPO/PACK EXPO collocation provides a great opportunity for attendees and vendors to share ideas,” says Kate Achelpohl, Director of Member Communications at PMMI. “For example, the food industry can gain insight on how to improve their food safety efforts by learning about the sterilization efforts the pharmaceutical industry has perfected over the years. Conversely, pharmaceutical manufacturers can learn about best practices in cold chain storage and delivery from the food industry. This shared space is a great environment for collaboration and cross pollination.”

You can register for Pharma EXPO at Registered attendees can purchase conference passes online for $140/session, $220/day pass or $500/full-conference pass.