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  • Four Steps to Conducting a Successful Data Integrity Audit

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  • Client/CMO Partnership Starts with the Quality Agreement

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  • Applying QRM to the Change Control Process

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  • Back to the Future

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  • A Line of Sight Approach for Assessing Aseptic Processing Risk: Part II

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  • What Recent FDA Warning Letters Can Teach Us

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  • Are You Prepared for the Industry’s Transformation?

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  • Keeping Current with Industry Trends and Emerging Technology

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  • PDA Summer Reading

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  • The Future is “Cloudy” for Data Integrity

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  • Make New Connections at the 2016 PDA/FDA JRC

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  • Workshop Offers DI Insights from Regulator, Industry

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  • Data Integrity and the Preapproval Inspection

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  • Another Step Toward Injection-Free Drug Delivery

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  • Speakers Offer EM Insights at Chapter Symposium

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  • Combo Products Put Control in the Hands of Patients

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  • Nurturing the CMO Partnership Lifecycle is Crucial

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  • Is Silicone Oil-Based Lubrication Still State-of-the-Art?

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  • Microbial Control to Ensure Product, Patient Safety

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  • Measuring the State of Quality Assurance in 2016

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  • PDA Shares Concerns about IDP Storage General Chapters

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  • 7 Steps for a Reproducible Cycle Development Plan

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  • Aseptic Processing Practices Discussed at Lively Workshop

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  • A Line of Sight Approach for Assessing Aseptic Processing Risk: Part I

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  • PDA Course, Technical Reports Trigger Success for Takeda

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  • NE Chapter Explores Technology Transfer in a "Modern Age"

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  • Drug Shortage is a "Wicked Problem"

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  • Big Data Meets Vaccine Manufacturing

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  • The Dangers of Underestimating Method Variability

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  • How Does Microbial Control Impact Patient Safety?

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  • Future of Research, Future of FDA Tied Together

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  • Combination Products Continue to be Key to Biologic Therapies

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  • Yes, We Can Meet the Challenges of Innovation

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  • One Coin, One Relationship When it Comes to Outsourcing

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  • New Trends Driving Prefilled Syringe Development

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  • Ireland Chapter Recognizes Young Scientists’ Work

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  • Reducing Analytical Method Steps for Accelerated Product

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  • PDA and FDA: A Long History of Collaboration

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  • Virus Retentive Filtration in Biopharmaceutical Manufacturing

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  • New USP Chapters Offer Visual Inspection Harmonization Hope

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  • When do ATMPs Fall Under GMP in the European Union?

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  • Biosimilars Offer Much to Consider for Biopharma

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  • Why is Patient Convenience Important?

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  • Best Practices for Leachables Under Development

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  • Quality by Design Also Applicable to Legacy Products

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  • Quality Metrics: An Ongoing Journey

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  • Missed Opportunities for Adventitious Agents Testing

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  • Pharma Seeks Long Tail of Flexible Manufacturing

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  • Compliance: Its Meaning for Industry, Regulators

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  • Defining New Expectations for Aseptic Processing

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  • Biosimilar Development Needs More Practical Guidance

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  • Survey of Industry Leachables Best Practices Completed

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  • Membership Survey Winner Nets Donation for Local Charity

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  • India Chapter Elects New Officers

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  • Pens, Injection Devices Get “Smarter”

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  • USP <790> Generates Industry Questions

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  • The Impact of Waste on the Cost of Quality

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  • Keep Your Facility Up-to-Date in a Complex Market

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  • Annex 1 Update: What Does it Mean for Industry?

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  • Quality Risk Management Meets Aging Facilities

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  • Make Memories at the 2016 PDA Annual Meeting

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  • Older Pharmaceutical Factories – What Does FDA Say?

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  • Four Steps to Modernizing Aging Control Systems

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  • The Future of the Glass Ampoule

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  • Building Agile, Flexible Facilities

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  • Don’t Be a Daredevil When Retrofitting Your Facility

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  • Chapter Seminar Explores Aseptic Manufacturing Concerns

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  • Managing Post-Approval Changes in a Global Environment

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  • EU Procedures for Transferring a Marketing Authorization

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  • Day 1 Sees Regulators, Industry Members Converge

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  • Visual Inspection as Part of a Stability Program

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  • Collaborative Spirit Pervades Day 2

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  • Chapter Tours United Airlines Cold Chain Cargo Facility

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  • Divergent Approaches to Stem Cell Regulation

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  • Experts Underscore Key Role of Data Integrity

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  • Case Studies in Bioburden Testing

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  • Career Breaks: Paths to Reentry

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  • New Age of Medicines Needs New Approaches

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  • Which Laboratory Software is the Right One For Your Lab?

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  • Hit the Sandbox to Achieve Product Development Success

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  • Change is Coming to FDA Inspections: Are You Prepared?

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  • Students “Meet the Professionals” at Chapter Event

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  • Closed System Filling Technology: A New Paradigm

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  • Biosimilar Developers Must Scale Mountains of Data

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  • Novel Therapies Need Novel Solutions, Flexible GMP

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  • Find Answers to Your Pressing Drug Delivery Questions

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  • Vaccines Prove Complex but Critical for Global Health Needs

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  • How Can Companies Meet Demands for Self-Care?

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  • Tools Available to Reduce Risk During Drug Development

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  • New Data Available on LPS and LER Phenomena

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  • GMP Oversight of Medicines Manufacturers in the European Union

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  • Missouri Valley Chapter Initiates New Student Chapter

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  • Quality Metrics Moves from Theory to Application

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  • Profiling Leachables in SUBs

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  • Science Driving New State-of-the-Art Practices for Microbial Control

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  • Why Firms Use the 0.45 μm Pore Size

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  • Cargo Firms Vital to Drug Supply Chain

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  • Designing a Successful Visual Inspection Program

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  • Micro’s Past Drives its Future State

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  • Continuous Manufacturing Reaches Tipping Point

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  • Quality Metrics: The Discussion Continues

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  • Are Your Documents Secure?

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  • Australia Chapter Tours New CSL Facility

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  • Maintaining Your Client/CMO Relationship

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  • Patient Wants Should Drive Syringe Design

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  • FDASIA: Three Years of Success

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  • USP <1116> and its Implications

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  • Inconsistent Expectations Clash with Best Practices

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  • PDA Member’s First Foray to Annual Meeting

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