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Quality & Regulatory Resources
Quality & Regulatory Resources
PDA promotes advances in the industry through strong relationships and dialogue with regulatory authorities around the world through various activities and resources. This page presents the full variety of PDA’s offerings related to quality and regulatory topics, including events and training, associated interest groups, publications, and news items.
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Upcoming Events
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1 Jan
Technical Report Live! TR-46 (Revised 2024): Last Mile - Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
- 1 January 2024 - 31 December 2027 7:00 to 8:00
- Online
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1 Jan
Technical Report Live! TR-68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
- 1 January 2024 - 31 December 2027 7:00 to 8:00
- Online
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1 Jan
Risk-Based Approach for Prevention and Management of Drug Shortages Webinar (PDA 299)
- 1 January 2024 - 31 December 2025 7:00 to 8:00
- Online
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31 Dec
On Demand PDA 578 Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
- 31 December 2024 - 31 December 2025 19:00 to 19:00
- Online
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31 Dec
On Demand PDA 592 ICH Q7 GMP for APIs
- 31 December 2024 - 31 December 2025 19:00 to 19:00
- Online
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11 Apr
Fundamentals of Quality Risk Management Training Course (PDA 529)
- 11 April 2025 11:30 to 19:00
- Palm Springs, CA
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13 May
Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers Training Course (PDA 272)
- 13 May - 14 May 2025 8:30 to 16:00
- Bethesda, MD
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10 Jun
Fundamentals of an Environmental Monitoring Program Training Course (PDA 102.3)
- 10 June - 12 June 2025 8:30 to 16:00
- Bethesda, MD
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17 Jun
Elements of GxP Training and Personnel Qualification Program Essentials Workshop (PDA 201)
- 17 June 2025 8:30 to 16:00
- Bethesda, MD
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14 Jul
Analysis of Environmental Monitoring Data Training Course (PDA 612.1)
- 14 July - 15 July 2025 9:00 to 12:00
- Online
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12 Aug
Exploring Container Closure Integrity (CCI) Testing Methods Training Course (PDA 109.1)
- 12 August - 14 August 2025 8:30 to 16:00
- Bethesda, MD
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13 Aug
Characteristics of Pharmaceutical Elastomers and Aluminum Seals in Parenteral Packaging Systems Training Course (PDA 808)
- 13 August - 14 August 2025 9:00 to 17:00
- Middletown, DE
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26 Aug
Risk-Based Approach to Airflow Visualization Training Course (PDA 802.1)
- 26 August - 28 August 2025 8:30 to 16:00
- Bethesda, MD
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11 Sep
Quality and Compliance Management for Virtual Companies Training Course (PDA 211)
- 11 September - 12 September 2025 8:30 to 16:00
- Washington, DC
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11 Sep
Contamination Control Strategy Essentials Workshop (PDA 293)
- 11 September 2025 8:30 to 16:00
- Washington, DC
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11 Sep
CMC Regulatory Compliance Strategy for Biopharmaceutical Manufacturing Training Course (PDA 526)
- 11 September - 12 September 2025 8:30 to 16:00
- Washington, DC
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11 Sep
Pharmaceutical Manufacturing Code of Ethics Training Course (PDA 297)
- 11 September 2025 8:30 to 17:00
- Washington, DC
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17 Sep
Fundamentals of Automated Visual Inspection Training Course (PDA 593.2)
- 17 September - 18 September 2025 8:30 to 16:00
- Bethesda, MD
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20 Oct
Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities Training Course (PDA 247)
- 20 October - 21 October 2025 8:30 to 16:00
- Bethesda, MD
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21 Oct
PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025
- 21 October - 22 October 2025 3:00 to 10:30
- Vienna, Austria
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11 Nov
PDA Visual Inspection Workshop 2025
- 11 November 2025 3:00 to 11:00
- Berlin, Germany
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17 Nov
Performing Microbial Data Deviation Investigations in the Pharmaceutical Industry Training Course (PDA 620)
- 17 November - 18 November 2025 8:30 to 16:00
- Bethesda, MD
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18 Nov
Design, Operation, and Qualification of Pharmaceutical Water Systems Training Course (PDA 399.1)
- 18 November - 20 November 2025 8:30 to 16:00
- Online
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19 Nov
Foreign Particulate Examination, Isolation and Analysis Training Course (PDA 120)
- 19 November - 20 November 2025 8:30 to 16:00
- Bethesda, MD
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Related Interest Groups
- Data Governance, Management, Integrity, and Digitalization
- Drug Compounding
- Facilities and Engineering
- Filtration
- Lyophilization
- Management of Outsourced Operations
- Microbiology/Environmental Monitoring
- Packaging Science
- Pharmaceutical Water Systems
- Pre-Filled Syringe
- Process Validation
- Quality Systems
- Regulatory Affairs
- Sterile Processing/Parenteral Drug Manufacturing
- Supply Chain Management
- Technology Transfer
- Visual Inspection of Parenterals
PDA Technical Glossary
A comprehensive technical glossary to understand the essential terms and concepts
ExploreBooks and Publications
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PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
PDA/ANSI Standard 03-2025: Standard Practice for Quality Risk Management of Aseptic Processes
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition
PDF Single UserMember price: $325.00 Nonmember price: $350.00
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