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 Fremont Stephen Buzzeo, Diversion Program Manager, DEA Scott Gerondale, Director Packaging Engineering, AMGEN Mike Zojaji, Global Suply Chain Packaging Manager, Bayer Abhishek Gautam, Senior Manager Packaging Engineering, Medtronic Nouri Istanbooly, Staff Engineering, Packaging Global Supply Chain & Logistic, Edwards Lifesciences 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 William Topa, 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 Fremont 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 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 William Topa, Account Executive, GlobalVision 14:45 Session Reserved for Abhishek Gautam, Senior Manager Packaging Engineering, Medtronic, on Medical Devices Packaging 15:15 Session Reserved for Optel Group 15:45 Afternoon refreshments and networking

4 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 Sharing methods on implementing the regulations of serialization in order to further improve strategies Think Tank Table 2 17:15 Creating innovative and cost efficient packaging for your medical devices to engage with your patients and ensure the protection of your product 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 10:15 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 Creating more robust relationships between document centric regulatory environments and content centric labelling and artwork processes

6 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 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 Discussing different ready to use innovative materials for temperature maintenance packaging 11:45 Revealing current research and development on upcoming cold packaging materials Deciphering the use of technology to aid packaging within extreme cold environments. Understanding how to implement a new type of packaging material within your packaging process Addressing the challenges of bringing new innovative materials onsite to avoid issues with the supply chain department 12:15 Nouri Istanbooly, Staff Engineering, Packaging Global Supply Chain & Logistic, Edwards Lifesciences Building the ultimate error- free labeling processes to contribute towards overall labeling operational success Identifying the shared errors in your labeling process to suggest great solutions Incorporating more updated technology to improve the speed and accuracy of labeling procedures Ascertaining key errors early on during the design of the artwork Refining internal labeling operations to further minimize labeling errors 12:45 Lunch and networking 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.

7 14:00 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. 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 Understanding why error free labelling takes place and how they can be avoided Bruce Suknanan, Manager, Regulatory Labeling, Regeneron Pharmaceuticals Chair s summary and close of conference