In this course, you will be able to identify why ISO 13485 is different from other quality system regulations and recognize management’s role in its implementation. You will also be able to recognize the main clauses of ISO 13485:2003 and why they are critical in terms of an overall quality system. Lastly, you will be able to identify how to prepare to implement ISO 13485:2003.

Yes

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FDA-regulated industries must work closely with FDA to comply with industry regulations and create safe and effective products. But how well do your employees know FDA?  “A Tour of FDA” serves as an excellent introduction to the organizational structure of FDA and gives an overview of the different enforcement actions available to this critical Agency.
Take a virtual ‘tour’ of FDA, learning about the function of each Center along the way. Afterwards, explore different actions the Agency may take in order to achieve compliance.

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This program addresses the application of GMP principles to microbiology laboratories and discusses the general principles of GMPs and their importance in microbiology laboratories. Aspects of laboratory operations specifically required by GMPs and considered industry practice will be reviewed, including: general GMP requirements for microbiology laboratories, documents and document control, handling of raw data, and laboratory control.

Coverage of general laboratory control issues will be the focus of the program and cover GMP requirements for topics, such as: handling of chemicals, documentation practices, sample handling, prevention of cross-contamination, positive and negative controls, identification tests, sterility tests,
handling of media, laboratory equipment, autoclaves, and environmental monitoring. This will be an excellent overview of specific laboratory requirements.

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In this course, you will review the specific requirements of Good Manufacturing Practices, or GMPs, as they apply to Analytical Laboratories. It is crucial to understand the impact that GMPs have on everyday laboratory practices. Compliance with GMP requirements is essential in order to create products that are both safe and effective.

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This course, the second in a three-part series, describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices that are required to meet FDA’s regulations. It outlines the kind of organization, policies and procedures, and plans FDA expects a manufacturing company to establish. This course draws on current industry good practice. Though it also draws on FDA medical device guidance, this course is not intended to describe an approach to developing software that subsequently becomes part of a medical device. Before taking this course, you should have successfully completed Requirements for Computerized Systems Validation and Compliance.

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In this course, you will be provided with a general awareness of FDA inspections of pharmaceutical testing and manufacturing facilities, including purpose, types, and areas/operations typically inspected. You will also explore how firms should handle FDA inspections and interact effectively with FDA Investigators. After completing this course, you will be able to have a general awareness of FDA inspections of pharmaceutical testing and manufacturing facilities including purpose, types, and areas/operations typically inspected. You will also be able to identify how firms should handle FDA inspections and interact effectively with FDA Investigators.

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This course defines batch records and describes how to properly perform a batch record
review. The course also covers the cGMP requirements for batch records and addresses how
to maintain cGMP compliance throughout the review process.
After completing this course, you will be able to define batch records and understand the purpose of reviews. You will understand the basic cGMP requirements for batch records. You will be able to explain the key elements and reasons for organized batch records and list many of the key components of batch records. You will identify the elements of compliance and completeness for batch records. Finally, you will understand the scientific and compliance reasoning behind product disposition decisions for many common product and process deviations, and documentation of these decisions.

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This course provides on overview of the fundamental compliance issues impacting the biotechnology industry. It examines compliance requirements specific to the biotechnology processes such as: cell culture and fermentation; culture media and growth; antibody production; extraction, isolation, and purification; cleaning procedures; and laboratory controls and testing. After completing this course, you will recognize what a biotechnology-derived product is. You will also be able to identify why and how FDA regulates them. You will also be able to identify the key manufacturing process for these products, as well as recognize the challenges involved with working with these products. Finally, you will be able to identify various controls for biotechnology-derived products.

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This lesson is designed to introduce the learner to those practices that control the handling and testing of drug product components, containers and closures while meeting requirements set forth in the GMP Regulations. The learner is introduced to these key concepts by observing a tour of a modern drug manufacturing facility. Proper procedures for the receipt, sampling, storage, testing, and record keeping of drug product components and containers and closures are covered in detail in this lesson.

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In this program, the concept of change control is presented in a way that places the learner in the role of a change control manager. Throughout the program, learners learn to state the key elements of a change control program, identify key indicators of change, and learn the regulatory requirements for change control. The program also defines how to identify the groups involved in change control and ways to describe the impact of change on product, process and people.

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GMP regulations require that the equipment used in the manufacturing of a drug, medical device, or biologic product be cleaned in such a way as to ensure that the quality, purity, and safety of a product will not be adversely affected. It is also important for manufacturers to set responsible limits for cleaning validation. After completing this course, you will be able to identify the advantages and disadvantages of common sampling methods. You will also be able to recognize the need for established limits of cleanliness in cleaning validation, as well as be able to utilize formulas to derive safe, practical cleaning limits.

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This course will educate the learner about the importance of properly responding to reports of alleged medical device problems. The learner will be able to apply the knowledge acquired to handle complaint events in a manner that is compliant with FDA regulations.

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This course enables you to identify the primary elements in an effective pharmaceutical complaint handling system. You will also recognize how to document complaint information as required by FDA regulations and understand the basic requirements for complaint evaluation and investigation. You will be able to recognize the types of complaints that must be reported to FDA according to the Adverse Drug Experiences regulations, and identify the importance of using statistical techniques to identify complaint trends that may indicate potential quality problems.

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This course has been designed by ISPE and UL EduNeering, Inc. in cooperation with the FDA/ORA, to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. The course explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. This course does not cover the detailed review of software that forms part of a medical device; it covers only inspection of systems that automate part of the device production process or part of the quality system.

Yes

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This course identifies the regulatory requirements and contents of an Annual Product Review (APR) as well as the possible benefits that APRs can yield. After completing this course you will know the regulatory requirements and contents of an APR as well as the benefits of a good APR program.

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The failure to take corrective and preventive actions can lead to continuing production problems, high scrap rates, product failures, customer dissatisfaction, and, most seriously, harm to a user or patient. When FDA determines that a company’s quality processes are not adequate or followed, they may take enforcement actions to prevent the distribution of the products produced by these processes.
After completing this course, you will be familiar with applicable regulatory requirements and other important aspects of implementing an effective corrective and preventive actions (CAPA) procedure. This course was prepared in accordance with FDA’s Quality System guidance and learning from the medical device industry. Implementing a CAPA system is a requirement for both the Pharmaceutical and Medical Device industry.

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This course provides an overview of the regulations found in 21 CFR Chapter 2 governing the manufacture and distribution of drugs classified as controlled substances by the Controlled Substances Act (CSA), and as enforced by the Drug Enforcement Agency (DEA).

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This course introduces the learner to FDA design control regulations by providing basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file, and human factors.

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The process of validation in FDA-regulated industry is important to gain FDA acceptance. Every step of a particular process must be documented with written procedures and validated with evidence. The key to successful validation is the understanding that validation must be documented. FDA issues Warning Letters to manufacturers that have inadequate validation activities. These observations are considered to be violations of GMP regulations and not violations of validation. This course provides the learner with an overview of the types of documentation that are at the core of sound validation programs. The learner is introduced to the primary documents of validation, as well as the documentation requirements for equipment, materials, processes and products, and personnel.

Yes

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No company wants to receive an FDA-483 or Warning Letter for adverse findings after an FDA inspection, but it does happen. If an FDA inspection yields any Good Manufacturing Practices (GMP) compliance concerns or faults during the inspection, FDA is required to fill out a report immediately. It is important to understand the purpose and scope of both FDA 483s and Warning Letters so as to be able to respond to them quickly and effectively. After completing this course, you will understand the basic principles of FDA 483s and their use, and the use of Warning Letters. In addition, you will recognize the significance of both these documents. You will also be able to describe the key aspects of written responses to both FDA 483s and Warning Letters

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Many important components and controls are necessary to assure high quality pharmaceutical or medical device products two of the most important are environmental control and environmental monitoring. Environmental control and monitoring go hand-in-hand. Together, they help to create and maintain a manufacturing environment that will prevent product contamination. This course examines the establishment of environmental control elements in the design of GMP operations and the monitoring necessary to assure proper function. It will review the importance of maintaining an acceptable manufacturing environment, including control parameters and related regulatory requirements.

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Injuries, fatalities, or major class action suits filed against the manufacturer can result when products are produced with out-of-calibration equipment. When lives are at stake and a company’s reputation is in the balance, equipment must always be operating to its precise specifications. This course is designed to help the learner identify the key concepts of calibration, and recognize the importance of calibration reference standards and GMP calibration requirements in order to ensure an effective calibration program.

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The European (EU)’s Medical Device Directive serves as the basis for the authorization to sell medical devices in the EU market. This training course provides specific information regarding the EU MDD and CE marking of medical devices, including how to assess conformity with the MDD, how to document conformity as well as incidents and events, and how to conduct post-market research and follow-up.

Yes

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The European (EU)’s Medical Device Directive serves as the basis for the authorization to sell medical devices in the EU market. Every employees needs to become familiar with the rules developed by regulatory authorities to keep the market flowing while maintaining accountability for medical device manufacturers.
This training course provides basic components of the EU Medical Device Directive, as well as the definitions and classifications that describe the devices that fall under this directive.

Yes

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Conducting a failure investigation in a pharmaceutical environment is a complex process. If the root cause of a failure is not properly identified, there may be additional failures or missed opportunities for improvement of product quality. An effective system for conducting failure investigations can provide a means for preventing recurrences. It is for these reasons that it is important for those in a pharmaceutical manufacturing environment to know the characteristics and requirements of a good failure investigation. This course will familiarize the learner with GMP regulations regarding failure investigations and the key components of a good investigation. Additionally, the learner will also be able to identify how to determine the “root cause” of a failure and recognize the importance of corrective actions and follow-ups to failure investigations.

Yes

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Effective personnel training and qualification can produce a competent workforce, which can lead to a reduction of errors/deviations, customer complaints, regulatory risk, and operational costs. This course will address the measures required to stay in compliance with FDA regulations, and the requirements needed to implement an effective training and qualification program.
This course will identify FDA requirements concerning training and qualification, responsibilities of personnel, records that need to be maintained, and how to measure training and qualification.

Yes

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Pharmaceutical batch records are essential to ensuring that regulatory and product quality attributes are achieved. In this course, you will explore the required components of batch records and the importance of carefully documenting the information generated during the manufacturing, packaging, and in-process testing of pharmaceutical products. This course is intended for manufacturing and packaging operators who perform functions directly related to producing a batch of material or product and who record critical data on batch records.

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This course reviews the principles of SOPs for an FDA regulated environment and provides employees with a working knowledge of what SOPs are, their purpose, how they are structured, information provided, change control, and how SOPs are used in the workplace. After completing this course, you will be able to identify what SOPs are, their purpose, and how they are structured. You will be able to recognize how to handle changes to SOPs, as well as how SOPs are used in the workplace.

Yes

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After completing this course, you will be familiar with the significant changes coming to the FDA in its stepped up emphasis on inspections, warning letters, enforcement, and follow up. You will learn about the challenges facing FDA and the industry with outsourcing manufacturing, and you will also learn about what companies can do to prepare for the coming changes.

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The Food, Drug, and Cosmetic Act requires Active Pharmaceutical Ingredients (APIs) to be manufactured in accordance with cGMPs. There are, however, no specific regulations in 21 CFR for APIs like there are for drug products. The FDA are proposing regulations, however, they are not yet final. This course is about the basic concepts of Good Manufacturing Practices (GMPs) and how they can be applied to the manufacture of APIs.

Yes

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In this course you will be able to identify important sources and types of contamination in a manufacturing environment, recognize the importance of health issues and personal hygiene, and describe the staged entry and use of cleanrooms. You will also be able to identify important practices and procedures for proper gowning. Before taking this course, make sure you have completed Principles of Aseptic Processing and Principles of Sterilization.
After completing this course, you’ll be able to identify important sources and types of contamination in a manufacturing environment, recognize the importance of health issues and personal hygiene, and describe the staged entry and use of cleanrooms. You’ll also be able to identify practices and procedures for proper gowning.

Yes

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“GxP” is a collective term for the regulations known as Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices.  Without these combined regulations the safety and efficacy of the pharmaceutical and medical device products would be in question.  After completing this course, you will know what practices comprise the GxP regulations. You will also learn how these practices relate to each step in the development and manufacture of new drugs, biologics, and medical devices. This course references regulations that can be found in the Code of Federal Regulations Title 21.

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Companies undergo product recalls for various problems; it could even happen to your company. A product recall is probably the most difficult and stressful situation that can be encountered in this industry. Because product recall can be critical, you need to understand what it is and how to handle it.
This lesson defines product recalls and explains their impact on the manufacturer, FDA’s requirements and enforcement when dealing with a product recall, and the basic steps for handling a recall.

Yes

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This course reviews the basics of handling an FDA inspection of a pharmaceutical and medical device manufacturing facility. The course will clarify the roles and responsibilities of personnel during an inspection with an emphasis on being prepared and maintaining a positive, professional relationship with FDA.

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Water is one of the most important materials used in the manufacturing of pharmaceutical and medical device products. Because water quality can directly impact product quality GMP regulations require that water receive the same scrutiny, monitoring, and control as any other critical raw material used in manufacturing processes. As a result, FDA investigators commonly cite manufacturing firms for their failure to assure the quality of water in use.
After completing this course, you will be able to identify the typical uses of water in pharmaceutical and medical device manufacturing. You will also be able to recognize the general process for producing high quality water, various approaches for monitoring a water system, and possible methods of solving water system problems.

Yes

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This course is designed to provide the learner with an understanding of the principles of drug stability testing and requirements for maintaining reserve samples. After completing this course, you will recognize the importance of maintaining drug safety and effectiveness over a product’s shelf life. You will be familiar with basic Principles of Stability and the relationship to product safety and effectiveness. You will also be familiar with reserve sample regulations and retention testing programs.

Yes

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This is the first in a series of courses designed to instruct on current good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers the Introduction to ICH Q7A and Quality Management for API manufacture. The learner should have a working knowledge of current GMPs for drug products as set out in the Code of Federal Regulations, CFR 21 Parts 210 and 211, as well as a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients.
After completing this course, you will be able to describe the purpose of the Q7A Guideline and how it fits in with current regulatory expectations and practices in the United States — especially in the context of the FDA’s systems-based inspections program, 7356.002F. You will also be able to recognize the basic terminology and applications of Q7A and the principles of an effective quality management system for API manufacture.

Yes

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This is the second in a series of courses designed to instruct on Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers qualifications for personnel, requirements for buildings used in API manufacturing, considerations for API manufacturing equipment, and materials management. Learners should have a working knowledge of current GMPs for drug products as set out in CFR 21 Parts 210 and 211. Learners should also have a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients. Learners should have completed the course ICH Q7A: Introduction and Quality Management.

After completing this course, you will be able to identify the general requirements for qualification of API manufacturing personnel. You will be able to identify the requirements for buildings and facilities as well as API manufacturing equipment. You will also be able to recognize materials management and warehousing and distribution procedures.

Yes

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Equipment qualification serves as the foundation for several currently recognized health care industry compliance requirements, such as analytical method, process, cleaning, and automated systems validation. A well-developed and established equipment qualification program allows a company to meet current GMP requirements and save operational costs at the same time. This course is designed to provide an introductory overview of the equipment qualification requirements that apply to the pharmaceutical, biotechnology, and medical device industries.
After completing this course, you will be able to define equipment qualification, identify the importance of equipment qualification, recognize the GMP requirements in this area, and identify the steps that must be followed in order to successfully implement equipment qualification.

Yes

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Interviews are an important part of virtually every operation performed by FDA inspectors, investigators, and analysts. Interviews are conducted during inspections, sample collections, recalls, and special investigations; therefore, it is important that FDA field personnel possess good interviewing skills and develop them as they move forward in their careers.
After completing this course you will be able to recognize the fundamentals of conducting an effective interview. You will be able to identify the traits of a successful interviewer and the importance of appropriate interpersonal skills. You will also be able to identify appropriate questioning techniques to use in an interview.

Yes

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This course provides an overview of FDA’s current Quality Systems Regulation for medical devices.  The content emphasizes the elements of a Quality System that help to ensure products are safe and effective and that manufacturing operations are compliant with current medical device Good Manufacturing Practices. This interactive program provides an overview of the major elements of a Quality System.

Yes

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This course is designed to describe the basic requirements for ISO 13485 -- the international quality management system for medical devices. The requirements of the standard apply to the methods used in, and the facilities and controls used for, the design and development, production, installation, and servicing of medical devices.  Requirements in the major clauses and sub-clauses of this standard are discussed.

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Updated to reflect recent FDA guidance, this course uses the making of a fictitious product to outline the actual activities that take place before, during, and following the validation of a process. You will learn terminology and key concepts related to the validation of manufacturing processes, the regulatory requirements for process validation, and validation approaches. A validation life cycle model is used to explain how major elements of validation relate to one another.

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Properly designed, constructed, cleaned, and maintained equipment lies at the core of the process control necessary to consistently manufacture pure, high quality drug products. In this interactive program you assume the role of the new manager of the Engineering Department. You will be involved in equipment selection, installation, qualification, and maintenance.
Upon completing this lesson, learners will be able to describe cleaning and maintenance practices for equipment used in manufacturing, as well as how a pharmaceutical company incorporates this equipment in their manufacturing. Additionally, learners will be able to identify the necessary documentation and records for equipment used in the manufacture of prescription and over-the-counter drugs.

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This course reviews effective measures for managing FDA inspections of pharmaceutical drug manufacturing facilities. The measures reviewed include preparation, interaction, handling, and follow-up. After completing this course, you will be able to identify various industry practices that are essential for managing FDA inspections effectively, including preparation before an inspection, elements of an FDA Inspection Guide, protocol for interacting with FDA, ending an inspection, and following up after the inspection.

Yes

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Mistakes or mix-ups in the critical areas of product packaging, labeling, and distribution can pose a danger to the consumer. This course provides you with information on current packaging and labeling requirements specified by the Quality System Regulation. A basic understanding of quality system regulations for medical device and equipment manufacturers (21 CFR 820), quality control procedures, and quality principles is a perquisite for this course.

Yes

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GMP regulations are very clear as to what training is required. This course introduces you to these training requirements and demonstrates how to apply them to actual FDA-regulated industry situations. You will also learn several varied approaches to training and understand the advantages and disadvantages of each.

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Learn the specific requirements set forth in the Good Manufacturing Practice Regulations (GMP’s) to assure the purity, safety, and effectiveness of returned and salvaged drugs when they are deemed suitable for distribution. This program examines the relationship of product complaints and investigations to drug products that have been returned or salvaged, and how these may impact what can be done with such drug products.
This program addresses the unique principles and practices involved in proper handling and processing of returned and salvaged products, GMP requirements, acceptable practices and procedures, and documentation are included in the lesson.

Yes

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This course examines the packaging and labeling of pharmaceutical products. Included is a discussion on the importance of these activities, possible impact of mix-ups that can occur with packaging or labeling, and the controls for these activities required by the cGMP regulations. In addition, typical approaches taken with packaging to protect consumers are reviewed. After completing this course, you will be familiar with GMP requirements for packaging and labeling, and the systems and procedures that prevent mix-ups.

Yes

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This course will provide the learner with an understanding of the change in enforcement policy of FDA for 21 CFR Part 11, Electronic Records; Electronic Signatures. The course discusses the Guidance for Industry; Part 11, Electronic Records; Electronic Signatures – Scope and Application, August 2003.

Yes

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The principle purpose of 21 CFR Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability, and compatibility with FDA’s mission of public health and safety.  This interactive lesson is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as FDA expectations for compliance. You will learn specific Part 11 requirements that govern the use of electronic records and signatures as well as FDA enforcement of Part 11.

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This lesson explores pre- and post-approval FDA inspections. The purpose and focus of each type of inspection are discussed with the key inspectional targets. For pre-approval inspections, the discussion focuses on the process and documentation related to demonstrating equivalence of the bio-clinical batches, raw materials, manufacturing process, finished product, and general GMP compliance. For post-approval inspection, discussion focuses on general GMP compliance issues. For each type of inspection, the various inspection outcomes are also covered.
Because all FDA-regulated facilities will undoubtedly be subject to FDA inspection, it is important that employees understand what to expect and what their role should be. When this lesson is completed, the learner will be able to discuss the differences between pre- and post-approval FDA inspections, why they occur, and possible outcomes of each.

Yes

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Because microbiological (bacteria, molds and fungi) and particulate contamination can potentially cause serious health problems in animals and humans it is vital that sterile products be manufactured, filled and packaged in a aseptic environment. This lesson will address the general principles and practices necessary to assure product sterility and safety related to aseptic processing. It will also address the principles of Good Manufacturing Practice Regulations (GMPs) as they apply to aseptic processing.

Yes

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The cleaning of equipment used in a pharmaceutical operation can be a complex process. Even the smallest amount of chemical residual material in equipment can be extremely dangerous—even deadly. It is for these reasons that FDA enhanced cleaning requirements for pharmaceutical manufacturers.
In this course you will learn the basics of cleaning validation in pharmaceutical manufacturing operations. The lesson will focus on cleaning procedures and the development of methods and approaches to validating your processes, and how to assess “clean” and developing methodologies for sampling and analyzing chemical residuals.

Yes

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This course reviews the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. The course also reviews how companies and their personnel should generally handle FDA inspections and interact effectively with Investigators.
After completing this course, you will be able to identify the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and areas/operations typically inspected. You’ll also identify how firms should handle FDA inspections & interact effectively with Investigators.

Yes

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This course discusses the basic principles of several commonly used sterilization techniques: moist-heat, dry-heat, gas, radiation, chemical, and filtration. It also provides an introduction to the microbiology involved in producing a sterile product. Finally, the key aspects of sterility assurance are discussed.
After completing this course, you will be able to define sterilization and list the most common sterilization methods. You will also be able to recognize the general approaches for validating and monitoring sterilization processes, and identify the key aspects of sterility assurance.

Yes

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This course introduces the Quality System (QS) Regulation (21 CFR Part 820)--a framework of basic requirements for manufacturers of finished medical devices. The course covers the history of the regulation, as well as its requirements, scope, and key terms. The course also discusses the manufacturer’s responsibility for a quality system under this regulation.

Yes

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The tenth in a series of Quality System (QS) Regulation courses, this course focuses on Servicing (21 CFR Part 820 Subpart N) and Statistical Techniques (21 CFR Part 820 Subpart O). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.
Statistical techniques may be employed to fulfill a number of QS Regulation requirements. Where statistical techniques are used, manufacturers must establish procedures for identifying valid statistical techniques.
After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the servicing and statistical techniques requirements of the QS Regulation
Learners should complete the previous courses in the series before taking this course.

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This is the eleventh and final course in the series of Quality System (QS) Regulation courses. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. This course focuses on the application and inspection of Quality System Regulation requirements within a medical device manufacturer’s quality system.
During inspections, FDA will assess whether a manufacturer has established procedures and followed requirements that are appropriate to a given device under the current state-of-the-art manufacturing for the specific device.
After completing this course, you will be familiar with the application and interrelationship of QS Regulation requirements within a medical device manufacturer’s quality system. You will also be familiar with the basic concepts of the Quality System Inspection Technique (QSIT), which is the inspection process currently used by the FDA to conduct Level 2 Baseline (Comprehensive) quality system inspections
Learners should complete the previous courses in the series before taking this course.

Yes

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The second in a series of Quality System Regulation courses, this course focuses on the management responsibility, quality auditing, and personnel requirements of 21 CFR Part 820, Subpart B. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Learners should complete QS Regulation 1: Overview and General Provisions before taking this course.

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The third in a series of Quality System Regulation courses, this course addresses design controls requirements of the Quality System Regulation. Learners should complete QS Regulation 1: Overview and General Provisions and QS Regulation 2: Quality System Requirements before taking this course.
Content for this course was provided by ISPE and reviewed by the US Food and Drug Administration as a result of a CRADA between UL EduNeering, Inc. and FDA

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The fourth in a series of Quality System Regulation (QS Regulation) courses, this course focuses on the Document Controls requirements of 21 CFR Part 820, Subpart D and the Purchasing Controls requirements of 21 CFR Part 820, Subpart E. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.  Learners should complete QS Regulation 1: Overview and General Provisions, QS Regulation 2: Quality System Requirements, and QS Regulation 3: Design Controls before taking this course.

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The fifth in a series of Quality System (QS) Regulation courses, this course focuses on Identification and Traceability (21 CFR Part 820, Subpart F) and Production and Process Controls (21 CFR Part 820 Subpart G). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.
The purpose of the Production and Process Controls requirements of the QS Regulation (21 CFR 820.70, 21 CFR 820.72, 21 CFR 820.75) is to ensure that manufacturers produce devices that conform to their specifications. Where any deviations from specifications could occur during manufacturing, process control procedures must describe the controls necessary to ensure the devices will conform to their specifications. Process control procedures also help to ensure consistency in manufacturing.
After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the Identification and Traceability, and Production and Process Controls requirements of the QS Regulation.
Learners should complete the previous courses in the series before taking this course.

Yes

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The sixth in a series of Quality System (QS) Regulation courses, this course focuses on Acceptance Activities (21 CFR Part 820 Subpart H) and Nonconforming Product (21 CFR Part 820 Subpart I). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.  Learners should complete the previous courses in the series before taking this course.

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The seventh in a series of Quality System (QS) Regulation courses, this course focuses on Corrective and Preventive Action (21 CFR Part 820 Subpart J). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.  The intent of 21 CFR 820.100 is to correct or prevent poor practices, not simply to correct or prevent bad product. Correction and prevention of unacceptable quality system practices should result in fewer nonconformities related to product.
Compliance with the corrective and preventive action requirements of the Quality System (QS) Regulation will allow a firm to monitor, identify, and react to existing product and quality system problems, as well as indicators of potential problems. These activities will help manufacturers identify opportunities to improve their products and quality system, as well as protect consumers by initiating field actions where necessary. After completing this course, you’ll be familiar with a manufacturer’s responsibilities relative to the corrective and preventive action requirements of the QS Regulation. Learners should complete the previous courses in the series before taking this course.

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This course is the eighth in a series of Quality System (QS) Regulation courses. This course focuses on Labeling and Package Control (21 CFR Part 820 Subpart K) and Handling, Storage, Distribution, and Installation (21 CFR Part 820 Subpart L). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.  The requirements of the QS Regulation relative to the Handling, Storage, Distribution, and Installation of medical devices are intended to help ensure that medical device mixups, damage, deterioration, contamination, or other adverse effects do not occur.
After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the labeling, packaging control, handling, storage, distribution, and installation requirements of the QS Regulation.
Learners should complete the previous courses in the series before taking this course.

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The ninth in a series of Quality System (QS) Regulation courses, this course focuses on Records (21 CFR Part 820 Subpart M). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. One of the basic themes of the Quality System Inspection Technique (used during inspections of medical device manufacturers) is the “Establish Test.” The QS Regulation requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.” Records play a vital role in FDA’s ability to confirm that procedures have been appropriately implemented and, on a broader scope, that an adequate and effective quality system has been established and maintained by the firm being inspected.
After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the records requirements of the QS Regulation.
Learners should complete the previous courses in the series before taking this course.

Yes

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This course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except the requirement for systems to be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.

Yes

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Obtaining an out of specification test result can be unsettling, and it is important that you know what to do with it. You will learn what the FDA says about handling batch or product samples that indicate out of specification results. You will also learn how to evaluate suspect results as well as how to conduct preliminary investigations in response to OOS results.
This lesson will provide you with the information to respond accordingly when an OOS result is encountered. Mastering this content will enable you to know what to look for and what to investigate when an OOS result occurs. It will also explain the cautions involved in handling data that may be related to OOS results, such as re-testing, averaging, and outliers.

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This course will explore the proper use of statistical techniques as they apply to medical device manufacturing. More than just a set of mathematical tools, the use of statistics in medical device manufacturing is now expected and regulated by the Food and Drug Administration in the Quality System Regulation, Subpart O, Statistical Techniques.

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This course will provide a general overview of bacterial endotoxins and the methods used to test for their presence in products. The specific techniques for conducting the gel-clot LAL test will be presented, including extensive discussion on standards and controls used. In addition, variations to the gel-clot test will be presented, including the chromogenic and kinetic alternatives, along with the advantages and disadvantages of each method.

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Both the pharmaceutical and medical device industries automate their manufacturing processes in order to make them more efficient, more accurate, and more consistent. As a result, the use of computerized systems in the pharmaceutical and medical device industry has become common. This lesson serves as an introduction to the design and development of process control software.
Compliance requires that manufacturers apply the principles and practices of software quality assurance to automated systems that may ultimately affect product safety and effectiveness. At the conclusion of this module you will be able to explain the software development lifecycle, including basic verification and validation activities, and describe several aspects of software quality assurance, including training and qualification of vendors.

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This course covers the definition and purpose of post-approval changes. In addition, it explores the four categories of change: Components and Composition, Scale of Manufacture, Site of Manufacture, and Manufacturing, and requirements for each level of change. You will learn about PAC guidance and how these documents are used to provide notification to FDA for post-approval changes to an approved drug application. You will examine the levels of PAC and the recommended chemistry, manufacturing, and control (CMC) requirements for each level. You will also explore the categories of change. Finally, you will be able to identify the tests and documents needed for each level and category of change.

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Recently FDA has become increasingly concerned with the number of Warning Letters being issued due to problems with the control of manufacturing processes. Items listed in these various Warning Letters include lack of validation of manufacturing processes, lack of written procedures, improper sampling and testing of materials, and failure to follow written procedures.
This course provides an understanding of what process control is. You will also learn about the written procedures involved in validation, how equipment affects process controls, batch production records, correct sampling and testing methods, proper reprocessing techniques, contamination control, and change control.

Yes

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This course discusses the process of vendor certification — a means of ensuring that a company is receiving the best possible materials, products, and services from its vendors or suppliers. This course covers the common practices and concepts associated with vendor certification. After completing this course, you will have a basic understanding of the value and process of vendor certification

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If you are directly involved in the manufacture and/or testing of a regulated product, chances are you are familiar with the role Standard Operating Procedures (SOPs) play in helping to establish a controlled manufacturing process. Understanding how SOPs are written and reviewed is an important insight into how quality products are manufactured. This lesson is designed to help you understand and recognize the principles and practices applicable to written procedures. You’ll learn the rationale and GMP requirements for written procedures as well as the different types of procedures and how they are developed. Additionally, you’ll become familiar with the format & content of a procedure.

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This course provides the learner with the information that should be included in a validation protocol. The learner is introduced to the key components of the protocol, such as information related to materials, equipment, and acceptance criteria. This course is an introduction to the importance and content of the documentation that comprises validation.
After completing this course, the learner will understand what validation protocols are. The learner will also be able to identify the three types of qualifications, as well as the properties of each qualification. The learner will also be able to describe the key elements involved in a validation protocol.

Yes

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