Content focuses on the role and elements of a quality management system, its impact on the overall risk management approach, and its implementation scientifically and pragmatically. Case studies could demonstrate risk management's purpose, elements, and implementation, a quality management system, and systems validation.
Guidance Documents
Artificial Intelligence (1)
Commissioning & Qualification (5)
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Good Practice Guide: Decommissioning Pharma Equipment & Facilities
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
Compounding (1)
Data Integrity (15)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Drug Shortages (1)
GAMP® (15)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Good Manufacturing Practice (1)
Knowledge Management (6)
- GAMP RDI Good Practice Guide: Data Integrity by Design
- APQ Guide: Cultural Excellence
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
Lifecycle Management (3)
Manufacturing Operations (1)
Microbiological & Viral Contamination Control (2)
Process Analytical Technology (4)
Project Management (1)
Quality Assurance (8)
- Guide: 503B Compounding
- Good Practice Guide: Process Validation
- APQ Guide: Cultural Excellence
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
- PQLI Guide: Part 3 - Change Management System
- The Cultural Excellence Report - Six Key Dimensions
Quality Control (1)
Quality by Design (4)
Regulatory (3)
Sustainable Facilities, HVAC, & Controlled Environments (2)
Validation (12)
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- Good Practice Guide: Process Validation
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Community Discussions
Community Discussions
Oct 05, 2024
Validation
Oct 01, 2024
Information Systems
Validation
Sep 30, 2024
GAMP®
Pharma 4.0™
Sep 19, 2024
Sep 18, 2024
Knowledge Management
Process Analytical Technology
Sep 07, 2024
Quality
Aug 29, 2024
Data Integrity
Pharmaceutical Engineering Magazine Articles
ISPE in the News
Latest
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Who Said It? Show up, show up, show up, and after a while the muse shows up, too. If she doesn't show up invited, eventually she just shows up.
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Countdown Timer to Annual Meeting
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Setup and Implementation of Digital Validation Tools
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Pharma 4.0™ Interconnected Facility Design and Construction
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Zambia to produce millions of livestock vaccine doses
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FDA confirms end of shortage for Lilly's weight-loss drugs
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Gilead licenses 6 manufacturers to produce HIV PrEP drug
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Lilly to develop $4.5B drug research, manufacturing hub
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Experts explain how Biopharma 5.0 will work
- US dockworkers suspend strike that would have hit drug supply
White Papers
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
September / October 2023
Regulatory Trends & Quality Initiatives - Shortages of essential medicines around the world have…
July / August 2023
Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…
Videos
iSpeak Blog Posts
Pharmaceutical Job Board
Pharmaceutical Job Board
Professional Development Training
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. Course Price: $300 (non-member) / $270 (member) Buy Now Return to Online Learning
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. Buy Now Return to…
GxPs for Leadership
This comprehensive course will equip you with the knowledge and skills to ensure GxP compliance and inspection readiness in the pharmaceutical industry. You will thoroughly understand regulatory requirements and learn about management's role in maintaining safety and quality. The course covers essential topics such as regulatory expectations, responsibilities in compliance, and consequences of non-compliance.
GMP Refresher
Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them." This course will provide an overview of History, Regulations, Quality Systems, and development, with a focus on distinguishing between QA and QC in GMP. It can serve as a GMP refresher for both individuals and companies and ensures that current key trends are covered. CEUs are provided once you achieve an 80% passing grade…
Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Course
The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations can use to assess and advance the state of quality within their organization. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and provides a range of sustainable and practical quality management improvement strategies.
GMP Fundamentals: Eleven-Part Bundle Series
Obtain a 10% Savings by Purchasing All Eleven Courses Overview ISPE is presenting an eleven-part series that will focus on the fundamentals of good manufacturing practices (GMPs). The series provides an overview of the regulations pertaining to GMPs and covers topics such as: manufacturing controls, product distribution, plant hygiene, documentation practices, buildings & facilities, organizational structure, and more. This offering gives users access to all eleven modules of the series and is intended to introduce GMPs for the new pharmaceutical employee or to provide an annual refresher for…
CAPA / RCA / Investigations Training Course
Coming Soon 2024 - CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity.
GMP Fundamentals: Holding & Distribution
In this course, you will learn the requirements for storing, handling, and distributing finished products to ensure they are stored properly and not contaminated or altered during transport. For a limited time, registration fees are waived for this course. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to Online Learning
GMP Fundamentals: Packaging & Labeling Control
In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices. During this course, you will learn about the FDA's pharmaceutical packaging and labeling guidelines. You will gain an understanding of the basics of packaging and labeling operations, including production and inspection processes, documentation, and record-keeping. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to Online Learning
GMP Fundamentals: Production & Process Controls
This course offers an overview of Good Manufacturing Practices (GMP) for medical product production and process control. You will learn about GMP compliance, product design and development, process validation, control systems, and quality control procedures. Regulatory requirements, including FDA and international standards, will be covered. Upon completion, you will understand the fundamental principles and practices of GMP in medical product production. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to…