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.
Related Guidance Documents
Commissioning & Qualification (5)
Compounding (1)
Data Integrity (15)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity Download - USD
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- 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 (2nd Ed) Download - USD
- 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® (16)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity Download - USD
- 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 (2nd Ed) Download - USD
- 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: Computerized GCP Systems & Data
- 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)
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 (Download) - USD
- APQ Guide: Change Mgmt System Download - USD
- APQ Guide: Mgmt Responsibilities & Review Download - USD
- APQ Guide: CAPA System Download - USD
- PQLI Guide: Part 3 - Change Management System
- Cultural Excellence Report Download - USD
Quality Control (1)
Quality by Design (4)
Regulatory (2)
Sustainable Facilities, HVAC, & Controlled Environments (1)
Validation (14)
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity Download - USD
- 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 5 (2nd Ed) Download - USD
- GAMP Good Practice Guide: Enabling Innovation.
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: Computerized GCP Systems & Data
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
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Pharmaceutical Engineering Magazine Articles
Leveraging GAMP® 5 Second Edition for Medical Devices
This article provides a brief introduction into the standards and regulations for medical devices…
Quality Considerations in Disaster Recovery: A Case Study
Due to the growing digitalization of the industry, we are highly dependent on information technology…
Calibration Performance Improvement Case Study
Calibration plays a critical role in ensuring a measurement instrument’s accuracy—especially if the…
Benefits and Challenges of Process Capability Metrics
Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical…
A Patient-Centric Review of ICH Q6A and ICH6B
The ICH Quality Discussion Group (QDG) has recommended contemporizing the specification setting…
Air Speed Qualification: At Working Position or Working Level?
The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the…
Risk Management for Avoidance of Drug Shortages
Shortages of essential medicines around the world have been an ongoing concern for patients…
A Systemwide Approach to Managing the Risks of Continuous Manufacturing
Understanding and managing risks to continuous manufacturing (CM) technology is central to any…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
ICH Q13 and What Is Next for Continuous Manufacturing
The creation of a new ICH guidance document, Q13, International Council for Harmonisation of…
Enhanced Intervention Detection in Aseptic Fill Using AI/ML
We will show how continuous, real-time capturing of data with immediate data analysis by an ML…
CMC Requirements for New Drug Registration in Latin America
The global pandemic has demonstrated that now, more than ever, we need to work toward a global…
Webinars Related to Quality
Concept and Discussion Papers
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…
May / June 2023
North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort…
July / August 2022
ISPE held an Expert Xchange on 18 January 2022 that included presentations and interactive exercises…
Videos Related to Quality
iSpeak Blog Posts Related to Quality
Expert Xchanges
Upcoming
None Available
Training Courses Related to Quality
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…
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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…
GMP Fundamentals: Control of Excipients, Components and Drug Product Containers/Closures
In this course, you will learn about the fundamentals and importance of GMP control in the pharmaceutical industry. Good Manufacturing Practices (GMP), is critical for ensuring the quality, safety, and efficacy of pharmaceutical products. This includes controlling excipients, components, and drug product containers/closures to meet specific standards and requirements, reducing the risk of contamination, degradation, or incorrect formulation. You will gain a deeper understanding of the role of GMP control in maintaining the integrity of the supply chain, and how following GMP guidelines helps…
GMP Fundamentals: Buildings and Facilities
A “GMP Facility” is a building that is used in the production of pharmaceutical and medical device products. The proper design, layout, function and control of such facilities is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course, learners will focus on understanding the building layout, safety, cleanroom conditions, as well as facility sanitation and ventilation of both production and support areas. In this On Demand course (part 4 of 11), you will learn the elements of GMP Buildings & Facilities, as required by regulation. Interactive Course…
GMP Fundamentals: Equipment
GMP equipment is used in the production of pharmaceutical and medical device products. The proper design, function, qualification and control of such equipment is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course learners will understand equipment design, size and location, cleaning & maintenance as well as the qualifications of GMP equipment. In this On Demand course (part 5 of 11), you will learn the elements of GMP equipment, as required by regulation. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade…
GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This…