Current speakers: November 27 th 28 th 2018 Burlingame, USA

Transcription

1 3 rd Annual Pharma and Device Packaging and Labeling West Coast Conference Bringing industry professionals to create streamlined operations within product packaging and labelling. November 27 th 28 th 2018 Burlingame, USA Current speakers: Torsten Vilkner, Director Manufacturing Operations, Boehringer Ingelheim Stephen Buzzeo, Diversion Program Manager, DEA Scott Gerondale, Director Packaging Engineering, AMGEN Deana Tolentino, Principal Scientist, Head of Labeling and Artwork, Exelixis Blane Stroh, Director, Commercial Manufacturing, Packaging & Labeling, Global Serialization Lead, Gilead Sciences Mike Zojaji, Global Suply Chain Packaging Manager, Bayer Abhishek Gautam, Senior Manager Packaging Engineering, Medtronic Bruce Suknanan, Manager, Regulatory Labeling, Regeneron Pharmaceuticals Jeff Barnell, Program Manager for Packaging Innovation, Medtronic Keyur Doshi, Senior Validation Manager, Anika Therapeutics Albert Elboudwarej, Packaging Development and Validation Subject Matter Expert, Varian Carla Vidal, Manager of Device and Drug Manufacturing, Dermira Keith Schlotthauer, R&D Sustaining Engineer Label and Packaging Specialist, Stryker Neurovascular Shubhra Kochar, Engineer II- Distribution Technology, Genentech Gabriella Naguib, Account Executive, GlobalVision Neil Gleghorn, CEO, Kallik

2 Pharma and Device Packaging and Labeling West Coast November 27 th Program Day One 08:00 Registration and refreshments 08:45 09:00 Chair s opening remarks Exploring the packaging and repacking of controlled substances by the DEA DEA overview and drug scheduling DEA required records and report: arcos, quota, theft and loss forms, DEA order forms, batch records, inventory cards (in process products); Biennial / year-end inventory and sales records Security: Labeling; Diversion methods; good faith inquiries; direct access employee screening, 6 packaging / repacking areas and security DEA office contact: registrant inquiries, drug theft and loss contacts Stephen Buzzeo, Diversion Program Manager, DEA 09:30 Session Reserved for Perigord 10:00 How to face the day-to-day challenges in pharmaceutical packaging, labeling and regulatory departments to result in a smoother operational pace Discussing a strategy where all relevant departments can work together such that processes are met within the timelines How to develop the right mind-set and organization for success Considering why escalation is good and how it can leave the functions working better together Torsten Vilkner, Director Manufacturing Operations, Boehringer Ingelheim 10:30 Morning refreshments and networking Exploring packaging readiness for new Biotech & Pharma product launches 11:00 Mike Zojaji, Global Suply Chain Packaging Manager, Bayer 11:30 Session Reserved for Loftware

3 12:00 Interview Learning the different possibilities of optimizing equipment for manual packaging and debugging equipment Gaining insight from a start-ups perspective on their methods to improving their manual packaging equipment What strategies do companies have in optimizing their equipment? Complying with the FDA regulations to gain approval for packaging equipment Exploring new updated equipment for manual packaging to further improve accuracy Understanding what resources are used to debug packaging equipment to save long term financial costs Carla Vidal, Manager of Device and Drug Manufacturing, Dermira 12:30 Lunch and networking 13:45 14:15 14:45 Case study: Tackling Serialization Implementation, Validation and Data Integrity Issues Exploring key areas to focus for implementing and validating a serialization process Understanding the impact of the lack of standard data format on integrating packaging, labeling and distribution partners Highlighting the data integrity risks due to incoherent data transfer Uncovering the procedural controls around operational phase beyond initial validation Presenting a Case Study on the challenges companies have faced when executing serialization requirements Keyur Doshi, Senior Validation Manager, Anika Therapeutics Why your labeling process is obsolete Pinpointing common sources of errors in your labeling process Using technology as a vehicle in improving processes Modernizing the labeling process Unveiling Case Study: ROI Gabriella Naguib, Account Executive, GlobalVision Exploring Packaging Sealing Equipment Design for Reduced Sealing Process Variability Discovering the impact of package sealing process variability on a given product from the very initial process development to ongoing process monitoring Uncovering the scope of use of seal peel strength test from sealing development process all the way to ongoing monitoring of current production processes Highlighting how the standard deviation associated with the measured seal strength value is impacted by upstream equipment variability Enhancing how decisions made based on the seal strength values across the life of product have a long-standing impact on safety and efficacy of the medical device packaging

4 Understanding how controlling upstream process variability via equipment design plays crucial role in maintaining high level of confidence in our current as well as new sealing processes Abhishek Gautam, Senior Manager Packaging Engineering, Medtronic, on Medical Devices Packaging 15:15 Session Reserved for Optel Group 15:45 Afternoon refreshments and networking 16:15 Think Tank Session Interactive Think Tank sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each Think Tank session lasts for 30 minutes, and delegates may attend up to 2 think tank table. Think Tank table 1 Think Tank Table 2 17:15 Understanding why error free labelling takes place and how they can be avoided Bruce Suknanan, Manager, Regulatory Labeling, Regeneron Pharmaceuticals Share sterilization implementation strategies to meet regulatory requirements in order to identify improvements in your company s current strategy Blane Stroh, Director, Commercial Manufacturing, Packaging & Labeling, Global Serialization Lead, Gilead Sciences Chair s summary and close of day 1

5 Pharma and Device Packaging and Labeling West Coast Conference Date: November 28 th Program Day Two 08:00 Registration and refreshments Chair s opening remarks 08:45 Exploring how new world business expansions, globalization of business, new material technology, new and more complex regulations and transportation technologies are changing the world of packaging Understanding the role of investing in technical know-how and having more technical people to create better packaging Highlighting the different physical factors to reduce damage during transit, increase efficiencies in transportations and general transit activities worldwide and understanding how this contributes remarkable to globalization and movement of goods worldwide Uncovering how packaging, labeling and transportation will be disrupted by the creation of a new industry of self-driving trucks and increased accuracy in on-time delivery Underlining how labels will become even more complex to print and process because of new regulations for over-the-counter drugs, but will show more uniform codes, nomenclature and similarity in text and color differentiation 9:30 10:30 Albert Elboudwarej, Packaging Development and Validation Subject Matter Expert, Varian Panel Discussion: Discussing the challenges for packaging combination products in order to reduce errors and damages Finding packaging and structural ideas to enable efficient packaging of combinations products Discussing the various conditions considered required when shipping the product to the client without compromising the quality of the product To incorporate engineering and design controls for medical devices into quality-based design strategies for a drugs or biologics Testing the reliability of the packaging to ensure a robust product during shipping Establishing the regulations regarding combination products in order to comply with all conditions Scott Gerondale, Director Packaging Engineering, AMGEN Jeff Barnell, Program Manager for Packaging Innovation, Medtronic Moderated by: Keren Sookne, Director of Editorial Content, PMMI Media Group, Healthcare Packaging Setting new benchmarks for proving compliance across both printed and electronic labelling within an ever changing regulatory environment

6 Creating more robust relationships between document centric regulatory environments and content centric labelling and artwork processes Substantiating both printed and electronic labelling content with regulatory documents Building connected and agile processes spanning print and electronic labelling that make it easier to prove compliance Using a rules based approach to simplify content collation and ensure compliance across global regions How these approaches de-risk M&A activity, accelerate the shift towards elabelling, and simplify contract manufacturing processes Neil Gleghorn, CEO Kallik 11:00 Morning refreshments and networking Keynote presentation: Evaluating packaging design and materials to reduce the impact of your packaging on environment Incorporating social responsibility when designing the packaging to maintain the integrity of the product Working with consumers for packaging design and educating them through labeling on sustainable packaging Implementing eco-friendly materials within packaging design to reduce waste and costs. Exploring the guidelines on using plastics and polymeric material for packaging Jeff Barnell, Program Manager for Packaging Innovation, Medtronic Panel Discussion: Managing the specific stakeholders to improve labeling and packaging approval processes 12:00 Deciding who the key stakeholder decision makers should be to reduce time delays Creating a strategy to approach stakeholder decision making with other departments Deciphering which departments should participate during the final decision making for artwork approval Encouraging better communication between stakeholders and the internal departments to ensure deadlines are met What non-valued processes can be eliminated during the approval process? Deana Tolentino, Principal Scientist, Head of Labeling and Artwork, Exelixis Moderated by: Keren Sookne, Director of Editorial Content, PMMI Media Group, Healthcare Packaging 12:45 Lunch and networking 14:00 Speaker Hosted Roundtables Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting,

7 interactive way to build your personal network and learn from the experience and expertise of others. Roundtable 1 Roundtable 2 15:30 Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables Checks and balance in labeling processes and review Keith Schlotthauer, R&D Sustaining Engineer Label and Packaging Specialist, Stryker Neurovascular Exploring innovative technologies to achieve temperature maintenance during the supply chain Shubhra Kochar, Engineer II- Distribution Technology, Genentech Chair s summary and close of conference