Everything you thought you knew about serialization and the 2013 DSCSA timeline has changed. Just last year, in 2017, the FDA announced an enforcement delay, but what does this mean to you? Breathe a sigh of relief, or continue pushing to get your company ready? Download this free e-book, with the latest DSCSA-compliant serialization success strategies, real-world implementation tips, and pitfalls to avoid.
A detailed timeline lets you know what’s changing, and how soon. 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.… Plus, learn how OPEN SCS will affect you!!!
ExpertsSourced In This Book
Senior Quality Compliance Officer
Almac Pharma Services
Excellis Health Solutions
Packaging Engineering Consultant
Endeavor Consulting Group
Vice President, Consulting
Project Management Quality Consultant
Senior Vice President
Chief of Technology
The new U.S. law
Drug Quality and Security Act of 2013
Key concepts of the U.S. federal law
The timing of the U.S. federal law
Serialization around the world
Global compliance: Flexibility is the key
Staffing & project management
Building a proper serialization team
Secrets to serialization project management
11 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
Nine coding/marking considerations for serialization
Vision system considerations
Label and panel redesign considerations
Impact on production line speeds and OEE
Impact on production/operations workflows
The supply chain: Beyond the four walls
Transaction models and the U.S. drug supply chain
Transaction implications of the four views
Minimizing the complexity of connections
Impact on wholesaler/distributors, pharmacies, clinics, and hospitals
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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