Download this free, 190-page e-book updated for 2014 with the latest serialization success strategies.
New federal legislation has passed, rendering state e-pedigree mandates, such as California’s, obsolete. Now what? This incredibly useful guide from the editors of Healthcare Packaging magazine has been substantially updated with the latest on the changes surrounding serialization. Easy-to-comprehend segments cover everything from assembling your serialization team, to pilot testing and more.
Written for the entire serialization team, from packaging through IT, this Playbook is jam-packed with hands-on, actionable advice from those who’ve been there. With extensive input from GS1, you’ll be up-to-date on standards and how the new legislation will change the serialization landscape.
Sourced in this e-book
Pharma Logic Solutions
Senior Quality Compliance Officer
Almac Pharma Services
Excellis Health Solutions
Strategic Business Planning, Track and Trace Projects
Packaging Engineering Consultant
Endeavor Consulting Group
Vice President, Consulting
Project Management Quality Consultant
Senior Vice President
Serialization Product Manager
How we got here
Impact of new federal Drug Quality & Security Act (DQSA) legislation
How and when it will go into effect
Business case for serialization
Are all of your company’s efforts to date wasted?
What about partial containers?
Staffing & project management
Building a proper serialization team
Secrets to serialization project management
10 steps to get started with serialization
11 routinely underestimated aspects of serialization
Line and plant strategies
Packaging line modifications for serialization
What “inference” is and why it matters
Strategies for accurate aggregation
Eight coding/marking considerations for serialization
Case study: Contract packager builds its own serialization solution
Questions to ask your CMO/CPO about serialization
Software & Architecture
Line and plant level software implications
Avoid these EPCIS interoperability pitfalls
Issues with master data
How to avoid the leading zero issue
Preventing counterfeit e-pedigree data
Pilot testing guide
Determining goals and metrics for pilot testing
Getting started with pilot testing
Pre-flighting your supply chain pilot
Lessons learned: project and vendor management
Lessons learned: on the packaging line
New GS1 help with pilots
Mixing serialized with non-serialized shipments
Downloadable Word document with actual language to help you get started with your project:
Sample user requirements starter document
Plus: Vendor Selection Resource Guide
Questions to ask serialization solution providers
Detailed profiles of vendors who can help implement your serialization program
Praise from early reviewers for Healthcare Packaging’s Pharmaceutical Serialization Playbook:
"You did a great job capturing the essence of what people need to know."
"I just wanted to pause to tell you that you have created an incredibly useful and usable document that will help people come up to speed quickly and avoid the same mistakes that the pioneers made."
"Very well written."
"I’ve read through the playbook and everything looks great. Great work by you and your team."
"I think this is going to be an amazing source of information for the pharma industry. Great job!"
"Great information and I know we will be using this as a guideline to a successful serialization implementation. I sent this playbook to some team members and they thought this was "EXCELLENT" and a "WELL DONE DOCUMENT"! Hope others see the value as we do. Thanks for all your efforts and keeping me in the know."
"The playbook is excellent. I’d imagine this will serve as a critical document for the industry."
"I am pleased with the content of the playbook. Your team did an excellent job putting this content together."
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