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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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31 Dec
On Demand PDA 578 Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
- 31 December 2023 - 31 December 2024 19:00 to 19:00
- Online
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31 Dec
On Demand PDA 592 ICH Q7 GMP for APIs
- 31 December 2023 - 31 December 2024 19:00 to 19:00
- Online
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9 Jul
PDA 538.3 Quality Culture Assessment
- 9 July - 10 July 2024 9:00 to 12:00
- Online
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23 Jul
PDA 102.3 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program
- 23 July - 25 July 2024 8:30 to 16:00
- Bethesda, MD
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31 Jul
PDA 399.1 Design, Operation, and Qualification of Pharmaceutical Water Systems
- 31 July - 2 August 2024 8:30 to 16:00
- Online
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1 Aug
PDA 621 Introduction to the Quality Risk Management Master Plan
- 1 August 2024 11:30 to 19:00
- Edmonds, WA
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20 Aug
PDA 109.1 Container Closure Systems and Integrity Testing
- 20 August - 22 August 2024 8:30 to 16:00
- Bethesda, MD
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27 Aug
PDA 802.1 Risk-Based Approach to Airflow Visualization
- 27 August - 29 August 2024 8:30 to 16:00
- Bethesda, MD
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27 Aug
PDA 808 Characteristics of Pharmaceutical Elastomers and Aluminum Seals in Parenteral Packaging Systems
- 27 August - 28 August 2024 9:00 to 17:00
- Middletown, DE
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12 Sep
PDA 576 Root Cause Investigation for CAPA
- 12 September - 13 September 2024 8:30 to 16:00
- Washington, DC
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12 Sep
PDA 515 The Impact of CGMPs on Biomanufacturing Facility Design and Operation
- 12 September 2024 8:30 to 16:00
- Washington, DC
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12 Sep
PDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making
- 12 September - 13 September 2024 8:30 to 16:00
- Washington, DC
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12 Sep
PDA 529 Technical Report No. 54: Foundations of Quality Risk Management
- 12 September 2024 8:30 to 16:00
- Washington, DC
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16 Sep
PDA 243 Current Good Manufacturing Practices CFR Parts 210 and 211
- 16 September - 19 September 2024 8:30 to 16:00
- Bethesda, MD
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16 Sep
PDA 531 Technical Report No. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools
- 16 September - 18 September 2024 8:30 to 16:00
- Bethesda, MD
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19 Sep
PDA 612.1 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines
- 19 September - 20 September 2024 9:00 to 12:00
- Online
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1 Oct
PDA 120 Foreign Particulate Examination, Isolation and Analysis
- 1 October - 2 October 2024 8:30 to 16:00
- Bethesda, MD
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10 Oct
PDA 306 Technical Report No. 65: Technology Transfer
- 10 October 2024 8:30 to 16:00
- Washington, DC
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21 Oct
PDA 569 Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases
- 21 October 2024 10:30 to 18:00
- Phoenix, AZ
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24 Oct
PDA 450 Learning, Knowledge Management and Impact: Moving from Theory to Practice
- 24 October - 25 October 2024 8:30 to 16:00
- Bethesda, MD
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24 Oct
PDA 211 Quality and Compliance Management for Virtual Companies
- 24 October - 25 October 2024 8:30 to 16:00
- Bethesda, MD
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24 Oct
PDA 546.1 Understanding Container Options and User Needs for Syringes, Cartridge Containers, Wearables and Drug Delivery Systems
- 24 October 2024 10:30 to 18:00
- Phoenix, AZ
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28 Oct
PDA 247 Fundamentals of Contamination Control, Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities
- 28 October - 29 October 2024 8:30 to 16:00
- Bethesda, MD
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4 Nov
PDA 283 Technical Report No. 43: Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing
- 4 November 2024 8:30 to 16:00
- Bethesda, MD
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5 Nov
PDA 417 Introduction to Visual Inspection
- 5 November - 6 November 2024 8:30 to 16:00
- Bethesda, MD
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19 Nov
PDA 620 Technical Report No. 88 Microbial Data Deviation Investigations in the Pharmaceutical Industry
- 19 November - 20 November 2024 8:30 to 16:00
- Bethesda, MD
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19 Nov
PDA 538.3 Quality Culture Assessment
- 19 November - 20 November 2024 9:00 to 12:00
- Online
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3 Dec
PDA Visual Inspection Workshop 2024
- 3 December 2024 3:00 to 11:00
- Berlin, Germany
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3 Dec
PDA 102.3 Technical Report No. 13: Fundamentals of an Environmental Monitoring Program
- 3 December - 5 December 2024 11:30 to 19:00
- Carlsbad, CA
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4 Dec
PDA 399.1 Design, Operation, and Qualification of Pharmaceutical Water Systems
- 4 December - 6 December 2024 8:30 to 16:00
- Online
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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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Related Interest Groups
- Data Governance, Management, Integrity, and Digitalization
- Drug Compounding
- Facilities and Engineering
- Filtration
- Lyophilization
- Management on 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
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