PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025

PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025 - Recap

Stay informed with the latest updates, announcements, and important details about the conference. Here you'll find everything you need to make the most of your experience, from session schedules to speaker information and event highlights.
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Be sure to stop by the PDA booth to meet Adonna Cox, Senior Manager, Membership & Chapters! While you're there, support a great cause—everyone who donates to the PDA Foundation will receive a free limited-edition PDA t-shirt. Don’t miss it!

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Limited Edition

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Topic-Related PDA Technical Reports

Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users

PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End User complements the information provided in Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment by going beyond manufacturer-focused issues and addressing issues specifically encountered within the last mile of the distribution of medicinal products and devices. This revision updates the original 2009 technical report to account for expanded regulations, the development and implementation of newer, more advanced technologies and supply chains that have become more extensive and complex. 

Technical Report No. 52: Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
Technical Report No. 52: Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
Anyone involved with the shipping and distribution of pharmaceutical products will benefit from Technical Report No. 52: Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain.
Technical Report No. 54-2: Implementation of Quality Risk Management for Pharmaceutical & Biotechnology Manufacturing Operation:Annex 1: Case Study Examples for Quality Risk Management in Packaging & Labeling
Technical Report No. 54-2: Implementation of Quality Risk Management for Pharmaceutical & Biotechnology Manufacturing Operation:Annex 1: Case Study Examples for Quality Risk Management in Packaging & Labeling
This report is intended to align with ICH Q9 and is one in a series of similar documents that provide additional examples of how to apply risk management tools across the product supply chain.
Technical Report No. 58: Risk Management for Temperature-Controlled Distribution
Technical Report No. 58: Risk Management for Temperature-Controlled Distribution

Technical Report No. 58 provides specific guidance on the identification, assessment, evaluation, control and review of risks in the distribution process, such as receipt, storage, handling and shipping of bulk, intermediate and finished pharmaceuticals, biological medicinal products and medical devices.

Technical Report No. 64: Active Temperature-Controlled Systems: Qualification Guidance
Technical Report No. 64: Active Temperature-Controlled Systems: Qualification Guidance

This guidance discusses the process of qualifying actively controlled spaces that are designed to maintain a stable and uniform temperature around the cargo for the duration of transportation or storage at any temperature range.

Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages

PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014. The approach to risk-based prevention of drug shortages presented in this revision remains unchanged. This revision focuses on updating references and progress related to the current regulatory environment, regional regulations and guidelines, and terminologies used for drug shortages that have since been published. Elements in the templates and forms included in this revision have been updated to reflect current regulatory expectations and terminology. Drug shortages have become more frequent, more severe, and longer-lasting globally since the early 2000s for a variety of reasons. Sustainable access to safe, efficacious, and high-quality products every time a patient needs them is just as important as the therapeutic advances that have transformed the lives and survival of patients worldwide. 

 

Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications
Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications
This report provides guidance on material selection and evaluation for suitability, syringe preparation and handling (including human factors), and drug product compatibility (physical and chemical) with the syringe materials and mode of delivery. Plastic syringes and ancillary devices, such as autoinjectors, are not within scope.
Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes
Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes

PDA Technical Report No. 73-2: Application of Medical Device Regulations, Annex I Requirements for Staked Needle Syringes is an addendum to PDA TR-73 and provides recommendations on preparing the required documentation of the device part of the PFS to facilitate obtaining an NB opinion.

Technical Report No. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging
Technical Report No. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging
This report provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers consistent and standardized quality criteria that can be used by pharmaceutical and medical device manufacturers for the visual inspection of incoming elastomeric components and aluminum seals, and by suppliers for outgoing inspection.
Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General Chapter <1790>: Visible Particulates in Injection. This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.
Technical Report No. 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Technical Report No. 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations

PDA Technical Report No. 84 (TR 84): Integrating Data Integrity Requirements into Manufacturing and Packaging Operations addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate data integrity controls in manufacturing operations applicable to paper-based, electronic-based, and hybrid systems. The case studies included in this technical report provide examples of how to assess current data integrity risks and implement the concepts presented in the report.

PDA Technical Report No. 85 (TR 85) Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers (single user digital version)
PDA Technical Report No. 85 (TR 85) Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers (single user digital version)
This technical report aims to provide clear technical guidance for the development and design of a process validation master plan using a risk-based lifecycle approach, and to provide a comprehensive overview of strategies that may be used to validate a manufacturing process or unit operations.
Technical Report No. 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
Technical Report No. 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing

This technical report is a consensus-based resource surrounding the challenges encountered in using complex package systems and introduces important elements to consider in decision-making. It also offers an examination of the technologies available for package integrity testing not yet established by peer-reviewed research.

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