A Tour of FDA

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.

Topics include:

• FDA background
• The organizational structure of the FDA
• Office Of The Commissioner
• Office Of Regional Affairs
• The six main program Centers
• Enforcement actions:
• Informal enforcement
• Formal enforcement

Approach to Computerized Systems  Validation and Compliance

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.

Topics include:

• Description of a suitable framework for successful validation and compliance
• Planning and reporting requirement for computerized systems validation
• Selecting a validation strategy
• Ongoing activities that the user firm should perform to ensure continuing compliance

Complaint Management for Medical Device Manufacturers

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.

Topics include:

• The FDA’s definition of a complaint
• Effective complaint handling systems, including CAPA
• Complaint file maintenance
• Investigating a complaint
• Requirements of the MDR regulation
• Analysis of complaint data

Computerized Systems Inspections in the Medical Device Industry

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.

Prerequisite:

• Requirements for Computerized Systems Validation and Compliance
• Approach to Computerized Systems Validation and Compliance.

Topics include:

• How computerized systems are used in the medical device industry
• How an investigator should approach computerized systems
• The focus of the investigator’s review

Essentials of an Effective Calibration Program

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.

Topics included:

• Calibration
• Calibration standards
• GMP requirements for the calibration program
• Essential elements for a calibration program

Gowning for Sterile Manufacturing

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.

Topics include:

• Why gowning is important
• Types of contamination
• Preparation in gowning rooms
• Gowning basics and procedures

Handling a Product Recall

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.

Topics included:

• Product recalls
• Steps in conducting a recall
• Roles and responsibilities during product recall
• Effect a recall on a company
• Who a company must communicate with during a recall

ICH Q7A: Introduction and Quality Management

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.

Topics:

• What is Q7A
• How APIs differ from drug products
• When Q7A guidelines apply to the API manufacturing process
• The purpose of quality management
• Key Production activity that ensures API quality
• Why a formal change control system is needed
• What complaints and recalls share in common

ICH Q7A: Resources and Materials Management

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.

Topics:

• Personnel qualifications
• Buildings and facilities requirements used for API manufacturing
• Process equipment requirements used for API manufacturing
• Purpose of materials management
• Storage/Distribution

 

Implementing an Equipment Qualification Program

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.

Topics include:   

• Importance of equipment qualification
• Equipment qualification protocol
• Design qualification (DQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance Qualification (PQ)
• Legacy equipment qualification (LEQ)

Introduction to GMPs

In this course, you’ll examine the history of GMPs, and explore the importance of training, as well as quality control and personal responsibilities. In addition, you’ll discover the importance of documentation and tracking practices.

Topics include:

• Procedures & Documentation
• Responsibilities
• Contamination Control
• Inspections

Principles of Aseptic Processing

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.

Topics include:

• Aseptic processing
• Controlling the aseptic processing environment
• Employee requirements for aseptic processing
• Preparing components for sterile products
• Media fill
• Environmental monitoring programs

Principles of Auditing

This program focuses on the purpose and conduct of internal and external quality audits. It discusses the purpose of conducting audits, and focuses on the benefits to be derived if audits are conducted properly. It begins with a discussion on establishing an audit program to achieve internal GMP compliance. The program of the lesson is on the actual preparation, conduct, and follow-up associated with an internal audit. Finally, the importance of establishing corrective action and follow-up and how these aspects of the audit program can yield opportunities and quality improvements will be illustrated.

At the conclusion of this program, you will be able to discuss the importance of an effective audit program, the benefits that can result, actual conduct of an audit, and how proper corrective action and follow-up yield the ultimate benefits of the program.

Topics include:

• Audits
• Types of audits
• Benefits of performing an audit
• Preparing for an audit
• Performing an audit
• Audit closeout

Principles of Cleaning Validation

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. In addition, assessing “clean” and developing methodologies for sampling and analyzing chemical residuals are discussed.

Topics include:

• Cleaning validation
• Choosing the proper cleaning method
• Why a cleaning Standard Operating Procedure is necessary
• Assessing “clean”
• Testing for chemical residues
• Proving methods
• Acceptance limits
• Testing and monitoring the cleaning procedures
• Control and monitoring procedures

 

Requirements for Computerized Systems Validation and Compliance

 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.

Topics include:

• Computerized or automated systems
• Regulations addressing the requirements for validating computerized systems
• Three types of validation
• How software differs from hardware
• Guiding principles for computerized systems validation and compliance
• IQ, OQ, and PQ as related to computerized systems validation
• FDA’s expectations for validation activities and documentation

 

For the entire course library with descriptions please download the UL EduNeering and AdvaMed Course Guide.