The answer to that question will be supplied in part at the Tuesday Keynote Session during Pharma Expo led by an FDA representative who will speak on “The Importance of Product Integrity: A Regulatory Perspective.” His presentation will focus on regulatory priorities and the importance of drug product security throughout the life cycle.

One of the threats to drug product security is drug counterfeiting, and Sharon Flank of InfraTrac will present solutions in the session “New Options in Anti-Counterfeiting.” “Companies need solutions cost effective enough to be used on all their products, not just their high-profile targets,” Frank will tell attendees. Advances in cost, portability and tagging coding will be discussed as examples of quality lapses that highlight the importance of identifying not only counterfeits, but “diverted products” as well.

Serialization promises to be a topic of great interest as four sessions are included in the day’s programs. In “GloPharbal Serialization Deployment” Marc Puich, Senior Vice President of Sales and Program Management, explores a “flexible approach” to global serialization deployment using Level 3 standardization. “The benefits of standardizing on Level 3, especially if MES is part of the roadmap, are significant,” says Puich. “Companies can build and maintain one interface to global systems, regardless of plant technologies.” Puich will discuss using an independent Level 3 solution globally in a MES/EBR environment and its integration into various Level 2 technologies.

Understanding pharmaceutical product serialization may be a challenge, but Atillio Bellman, Practice Director of Serialization and Technology at Adept Packaging, will provide “A Comprehensive Overview” of serialization, where he will inform attendees about “effective and efficient ways to learn about the complexities and inter-dependencies of serialization” and its “broad impact to operations and our supply chain.” Bellman will discuss how there are “only a handful” of industry veterans with a high level of experience in serialization regulation, but those with experience are becoming more numerous, fortunately. These professionals can help their firms better understand how to meet serialization compliance requirements.

Serialization continues to be a topic in “Tools for Successful Serialization Implementation,” where Clarke Engineering Project Engineers Elizabeth Weaver and Christopher Washington will suggest that regulatory requirements for serialization are “pushing pharmaceutical manufacturers to adopt new technologies in order to maintain compliance.” Both will layout the challenges to professionals involved in serialization, among which are identifying how new regulatory requirements impact them and finding solutions that integrate new technologies into existing structures.

There are technologies that can help meet FDA serialization requirements. In “Using Technology to Meet FDA Serialization Requirements,” Bosch Project Manager Daniel Sanwald will provide technical solutions to serialization issues that will aid in the effort to make the supply chain safer from threats such as counterfeit drugs. “To make the supply chain safer, worldwide laws regulating the serialization and traceability of pharmaceutical packages will come into force in the coming years,” says Sanwald. He will discuss the influence of packaging materials and print and control systems in conjunction with IT systems and market demands.

During “A Global Approach to Serialization,” speaker David DeJean, Vice President of Center of Excellence at Systech International, will explain how to “drive value throughout your organization beyond compliance.” A ‘best practices’ approach to serialization will include long-term strategies and tools up to the challenge of the mandated regulations will not only meet the demands, but exceed them, suggests DeJean.

Two presentations in “The Next Big Thing for Nutraceuticals” will suggest that “State-of-the-Art GMP Production” is one new big thing and the second is the scientific arrival of ayurvedic and botanical ingredients.  According to ModWave President Par Almhem, nutraceutical products, such as vitamin preparation, mineral nutrients or dairy products are getting more popular and as a result are facing more scrutiny for efficacy, side effects and quality. New manufacturing facilities and new processes are being designed to meet the regulatory challenges and this presentation will not only spell out the challenges and opportunities as well as the issues, but also offer solutions to problems in meeting them.

The second “big thing” is the meeting between ayurvedic and botanical ingredients and clinical trials and the scientific backing that may result.  Speaker Rajiv Khatau, Managing Director at Lodaat Pharma, will answer the question ‘What can modern science learn from Complimentary Alternative Medical (CAM) ingredients and why a 5,000 year-old technique is not necessarily out-of-step with ICH/GMP guidelines.

Over the last five years, “training deficiencies” ranked in the FDA’s top 10 reasons for issuing 483s? Speakers Adam Sais of the US Veterans Administration and Kenneth Montano of the VACSP Clinical Research Pharmacy Coordinating Center will offer a solution in the form of a well-designed competency program that demonstrates each employee’s learning and their ability to complete and understand job tasks in “Eliminating 483’s Based on Regulatory Observations.”

“Our model can be built to guide and support organizational strategy to sustain a quality culture and employee engagement,” say Sais and Montano. Their presentation will explain how their program meets regulatory requirements and assures high standards of job performance.