Bloodborne Pathogens -- General Industry

Identify the risks of working around bloodborne pathogens, the controls in place to eliminate or reduce those risks, and the equipment that can help ...

Bloodborne Pathogens -- Healthcare Workers

Recognize the definition of bloodborne pathogens and identify some of the diseases they can cause. Recognize controls and procedures that can lower ...

Fire Safety for Healthcare Workers

Recognize the sources of heat, oxygen, and fuel that can start a fire. Recognize regulatory considerations for healthcare facilities regarding fire ...

Documenting the Drug Development Process ICH Q8(R2)

Recognize the guidance from FDA covering the documentation of pharmaceutical drug development. Identify how the guidance can be used to consistently ...

Hot Work Permits

Identify the process of hot work area evaluation. Recognize the contents of a hot work permit. Recognize the responsibilities of management, workers, ...

Q9: Quality Risk Management

Identify the methodology and tools used in a risk management process. Recognize the operational areas where risk tools can be used to increase ...

The Clinical Development Process: Investigational Product, Plan, and Data Management

Identify the steps leading to the final FDA review and approval for marketing of a new product.

FDA Establishment Inspection (EI)

Identify the statutory authority for establishment inspections. Recognize the procedures to prepare for, conduct, and conclude inspections.

Combustible and Flammable Liquids

Identify guidelines and precautions for handling, transporting, and storing combustible and flammable hazards found in your workplace. Recognize ...

Computer Workstation Safety

Identify common RSIs, their symptoms, their causes, and exercises and other safety measures that can help you prevent them.

Privacy and Data Protection

Recognize what personal information must be protected according to the law and our company policies, as well as your personal responsibility in ...

Quality Systems Approach

Identify FDA’s guidance on modern quality systems and recognize how this can foster GMP compliance, innovation, and continuous improvement in the ...

QSIT 1 -- Beginning the Inspection

Recognize the origin and scope of QSIT. Recognize the basic concepts associated with how to sample records for review during an inspection conducted ...

QSIT 2 -- The Management Controls Subsystem

Identify the seven Inspectional Objectives associated with the Management Controls subsystem and recognize some of the ways to accomplish those ...

QSIT 3 -- The Design Controls Subsystem

Identify the fifteen Inspectional Objectives associated with the Design Controls subsystem. Identify some of the ways to accomplish those objectives.

QSIT 4 -- The Corrective and Preventive Actions Subsystem

Identify the ten inspectional objectives associated with the CAPA subsystem and recognize the ways to accomplish those inspectional objectives.

QSIT 5 -- The Production and Process Controls Subsystem

Recognize the six inspectional objectives of the Production and Process Controls subsystem and techniques for accomplishing those objectives.

Systems Based Drug Inspections

Recognize the guidance provided by FDA for investigators inspecting drug firms for GMP compliance. Recognize the guidance provided in CP 7356.002 ...

ICH Q7A: Introduction and Quality Management

Recognize the purpose of the Q7 Guideline and how it fits in with current regulatory expectations and practices in the United States — especially in ...

Part 11: Electronic Records and Signatures -- Changes in Enforcement Policy

Recognize FDA expectations for compliance with all applicable predicate rules. Identify how the Agency plans to interpret and enforce Part 11 with ...

Part 11: Electronic Records and Signatures -- Application

Recognize how to apply Part 11 regulations to your company’s systems and records in accordance with FDA’s expectations. Identify what records are ...

Part 11: Electronic Records; Electronic Signatures

Identify the regulatory requirements for electronic records and electronic signatures. Recognize FDA expectations for compliance.

Computerized Systems Inspections in the Medical Device Industry

Recognize where computerized systems are used in the medical device manufacturing process. Recognize FDA’s approach to inspecting computerized ...

Auditing of Computer System Validation to Ensure Data Integrity

Recognize the requirements for data integrity, validation activities, and documentation. Recognize an approach to inspecting computerized systems ...

Physical and Network Security

Recognize security risks to our company’s physical and virtual assets. Identify your responsibilities for protecting all of these resources. ...

ICH Q7: Resources and Materials Management

Identify the general requirements for qualification of API manufacturing personnel. Identify the requirements for buildings and facilities as well ...

Introduction to GMPs

Recognize cGMPs and their importance to the pharmaceutical and medical device manufacturing industry. Identify basic cGMP requirements and the roles ...

Awareness of FDA Inspections for Pharmaceutical Manufacturers

Identify the basics of FDA inspections of drug manufacturing facilities, including authority, purpose, types, and the areas/operations typically ...

Pre- and Post-Approval FDA Drug Inspections

Recognize what constitutes a pre- or post-approval inspection. Recognize what possible outcomes may result. Identify some helpful recommendations for ...

Handling an FDA Inspection

Recognize the elements of an FDA inspection and your role during the inspection. Identify how an inspection is conducted and how to conduct yourself ...

Effectively Responding to FDA 483s and Warning Letters

Recognize the basic principles of FDA 483s and the use of Warning Letters. Recognize the significance of both these documents. Identify the key ...

Vendor Certification for Pharmaceutical Manufacturers

Identify regulator concerns about supply chain quality Recognize new regulations and guidances coming into effect. Identify critical supplier quality ...

GMP Updates: Supply Chain Quality and Emerging Compliance Concerns

Recognize the critical concerns of supply chain quality in the medical device and pharmaceutical industries. Identify the challenges manufacturers ...

Combination Products – cGMP Requirements

Identify the four different types of combination products. Recognize the scope of the new regulation in 21 CFR Part 4, and each of the drug, device, ...

Management Responsibility for Quality: What FDA Expects

Identify management’s specific responsibilities in developing and maintaining a Quality System.

European Union GMP Requirements

Identify the EU’s basic GMP regulations and recognise how you comply with these requirements.

Validation of Analytical Laboratory Procedures

Identify applicable regulatory requirements. Recognize the important aspects of analytical methods validation, including the data that must be ...

Data Integrity for Quality Control Laboratories

Recognize the history of data integrity. Identify the types of data integrity issues found by FDA. Recognize possible consequences of data integrity ...

Good Documentation Practices for Medical Device Manufacturers

Recognize the critical importance of creating and maintaining good documents. Identify the stages of the Documentation Life Cycle. Recognize ...

FDA 483s: Inspectional Observations

Recognize the purpose of issuing an FDA 483. Identify what kinds of inspectional observations are included on an FDA 483, when it is issued to the ...

An Introduction to ISO 13485 - The Quality Management System for Medical Devices

Recognize the difference between ISO 13485 and ISO 9001. Recognize the process approach of ISO 13485. Identify management’s role in implementation ...

A Guide to ISO 13485 - The Quality Management System for Medical Devices

Recognize the specific requirements of ISO 13485.

Principles of Good Documentation

Recognize the importance of good documentation practices. Identify common forms of documentation used during the manufacturing process and the ...

Laboratory Safety

Identify the types of hazards that make a laboratory unsafe. Identify how to prevent or eliminate these hazards through compliance with safety ...

PPE Assessment

Recognize how to perform a workplace hazard assessment for PPE. Identify what hazards to look for. Recognize how to collect and organize assessment ...

Walking and Working Surfaces — Affected Person

Recognize hazards common to walking and working surfaces. Identify how to prevent hazards to walking and working surfaces.

National Patient Safety Goals

Identify standardized credentialing training for HCIRs. Recognize the five substantive training areas recommended for HCIRs. Identify how this ...

Basics of PhRMA Code

Recognize how the PhRMA Code impacts your interactions with healthcare professionals.

Basics of the AdvaMed Code

Recognize how the AdvaMed Code guides your interactions with HCPs.

Reporting Adverse Events for Medical Devices

Identify what a medical device report is and the types of reports that exist. Recognize a company’s requirements for reporting adverse events for ...

Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (MA Regulation)

Recognize the provisions of the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation (MA Regulation), 105 CMR 970.000. ...

MedTech Europe Code of Ethical Business Practice

Recognize the guidelines that apply to the many types of interactions between MedTech Members and HCPs and HCOs. Recognize the importance of ...

Medical Device Filings: 510(k), PMA, and IDE

Identify the essential elements of the 510(k), premarket approval (PMA), and Investigational Device Exemption (IDE) filing processes for medical ...

Regulatory Requirements for Medical Devices in the Republic of Korea

Identify the regulations that apply to the marketing of medical devices in Korea. Recognize upcoming changes to those regulations as well as aspects ...

Collecting Samples and Establishing Limits for Cleaning Validation

Identify advantages and disadvantages of commonly used sampling methods. Recognize the need for established limits of cleanliness in cleaning ...

Documenting Validation Activities

Recognize FDA’s definition of validation. Identify the requirements for cGMP compliant documentation of validation processes.

Physician Payment Sunshine Act

Recognize the meaning and purpose of the Physician Payment Sunshine Act. Recognize the definition of key terms and phrases, such as, “applicable ...

HIPAA and Privacy Guidelines for Medical Device Sales Representatives

Recognize the basic provisions of the HIPAA Privacy Rule. Recognize how HIPAA affects our detailing and customer support activities. Identify how to ...

Principles of Sterilization

Recognize the definition of sterilization and identify the most common sterilization methods. Recognize the general approaches for validating and ...

Principles of Aseptic Processing

Recognize the general principles and practices necessary to ensure product sterility and safety. Identify the Good Manufacturing Practices (GMP) ...

A Step-by-Step Approach to Process Validation

Recognize the definition of process validation as it relates to pharmaceutical products and medical devices. Identify the steps involved in process ...

Key Concepts of Process Validation

Identify applicable regulatory requirements. Recognize important aspects of process validation. Identify the components of the validation life ...

Data Integrity: The Role of Quality Assurance for Data Integrity

Recognize the definition and importance of a process approach to quality, and recognize activities that help maintain quality of data. Identify ...

Data Integrity for Clinical Research Staff

Identify the role of clinical staff in data integrity. Recognize the importance of data integrity and various challenges to data integrity. ...

Review of Basic Statistical Techniques

Recognize how to interpret data using basic statistical techniques. Recognize how to solve technical problems in a straightforward manner and comply ...

A Tour of FDA

Recognize FDA’s public health mission and how the Agency is organized to carry out its mission. Recognize the history of FDA and the products that ...

Application of GMPs to Analytical Laboratories

Identify cGMP requirements as they apply to analytical laboratory practices. Recognize key concepts related to laboratory documents, raw data, and ...

The Design and Development of Software Used in Automated Process Controls

Identify the SDLC under regulatory requirements for the design, development, and control of software used in automated process controls. Recognize ...

Application of GMPs to Microbiology Laboratories

Identify the importance of handling raw data. Recognize the key approaches for ensuring accurate results. Recognize how to monitor, validate, and ...

ISO 14971: Risk Management for Medical Devices

Recognize Risk Management’s role towards medical devices product safety. Idenitfy the elements of the risk management process. Recognize the purpose ...

ICH GCP Obligations of Investigators Conducting Clinical Trials

Recognize how to comply with GCP guidelines. Identify principal obligations with respect to qualifications and agreements, Institutional Review ...

Ethics as the Foundation to Clinical Research

Identify the ethical components of the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, the International Conference on Harmonisation ...

Informed Consent

Identify key historical events that led to the current informed consent regulations and guidelines. Recognize the informed consent process as well ...

The Role of the Clinical Research Coordinator

Identify the CRC’s key roles in research and patient protection from pre-study visits through study completion.

Financial Disclosure by Clinical Investigators

Recognize the types of financial arrangements that must be disclosed and the requirements for proper financial disclosure for covered clinical ...

Administrative Roles of the Clinical Research Coordinator

Identify the role of a CRC throughout a clinical trial, as well as recognize applicable Good Clinical Practice standards.

Design Control Regulations for Medical Device Manufacturers

Recognize the purpose and scope of design control regulations. Identify the eight main aspects of design control and how they affect medical device ...

Medical Device Packaging, Labeling, and Distribution

Recognize the requirements for the packaging, labeling, and distribution of medical devices.

Quality Systems Inspection Technique (QSIT)

Recognize how to properly prepare for a Quality Systems inspection.

Introduction to the Quality System Regulation (QSR)

"Recognize the application of GMPs to the manufacture of medical devices. Identify the components of a quality system. Recognize the elements of ...

Good Clinical Practices (GCPs) for New Product Investigations

Recognize the basic concepts and key elements of GCP, including documentation, purpose, subject protection, and regulatory authority requirements.

Protection of Human Subjects in Clinical Trials

Identify the measures that are in place to protect the rights and welfare of subjects in clinical studies. Recognize informed consent requirements ...

High Purity Water Systems

Identify the typical uses of water in pharmaceutical and medical device manufacturing. Recognize the general process for producing high quality ...

QS Regulation 1: Overview and General Provisions

Recognize the origin and scope of the QS Regulation. Identify the purpose of the Preamble and general requirements of a quality system. Recognize key ...

QS Regulation 2: Quality System Requirements

Recognize the QS Regulation requirements associated with a firm’s management responsibility, quality auditing, and personnel.

QS Regulation 3: Design Controls

Recognize the design control requirements of the QS Regulation Recognize the terms associated with design controls. Recognize requirements for ...

QS Regulation 4: Document and Purchasing Controls

Recognize the document and purchasing controls requirements of the QS Regulation. Recognize document and purchasing control procedures that ...

QS Regulation 5: Identification and Traceability; Production and Process Controls

Recognize a manufacturer’s responsibilities relative to the Identification and Traceability, and Production and Process Controls requirements of the ...

QS Regulation 6: Acceptance Activities; Nonconforming Product

Recognize a manufacturer’s responsibilities relative to the Receiving, In-Process, and Finished Device Acceptance. Identify the Acceptance Status ...

QS Regulation 7: Corrective and Preventive Action

Identify a manufacturer’s responsibilities relative to the corrective and preventive action requirements of the QS Regulation.

QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution, and Installation

Recognize a manufacturer’s responsibilities relative to the labeling, packaging control, handling, storage, distribution, and installation ...

QS Regulation 9: Records

Identify a manufacturer’s responsibilities relative to the records requirements of the QS Regulation.

QS Regulation 10: Servicing; Statistical Techniques

Recognize a manufacturer’s responsibilities relative to the servicing and statistical techniques requirements of the QS Regulation.

QS Regulation 11: Application and Inspection of QS Regulation Requirements

Recognize the application and interrelationship of QS Regulation requirements within a medical device manufacturer’s quality system. Identify the ...

Principles of Auditing

Identify the definition of an audit and the benefits audits provide. Recognize how to develop an audit team and what the team should address during ...

Operating Room Conduct

Recognize elements of the hospital environment and the OR itself. Recognize proper behavior prior to and upon arrival at the hospital. Recognize ...

MDR Regulation 2: Device User Facility, Importer, and Manufacturer Reporting Requirements

Recognize important terms crucial to the device user facility requirements of the MDR regulation. Identify the MDR requirements as they relate to ...

MDR Regulation 3: Requirements for Individual Adverse Event Reports

Identify how user facilities, importers, and manufacturers report adverse events. Recognize the proper forms to use to report adverse events, as ...

MDR Regulation 1: Overview and General Provisions

Identify the key characteristics of the MDR regulation and its preamble as well as the key terms used in the MDR regulation. Recognize to whom the ...

EU In Vitro Diagnostic Regulations (IVDR)

Recognize essential requirements and harmonized standards for in vitro diagnostic medical devices. Identify significant legislative changes made to ...

EU Medical Device Regulation (MDR)

Identify the basic components of the EU Medical Device Regulation. Recognize the definitions and classifications that describe the devices that fall ...

Good Laboratory Practices (GLPs)

Recognize the general characteristics of GLPs. Recognize how GLPs apply to nonclinical studies

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations

Identify the role of the Postmarketing Adverse Drug Experience Reporting Compliance Program in monitoring and enforcing the drug safety reporting ...

Investigational Product Development

Recognize drug development phases as well as the main purpose of each phase. Recognize how each phase of new product development contributes ...

Q10 Pharmaceutical Quality System

Identify the approach to take in ensuring the pharmaceutical Quality System has the important principles needed to meet regulatory guidance.

ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials

Identify the specific requirements of ISO 14155. Recognize the roles and responsibilities of sponsors and monitors in clinical investigations of ...

Global Regulatory Strategy and Planning Process

Identify the elements of a regulatory strategy and plan that can meet your company’s development needs while meeting regulatory submission ...

Import Operations 2: The Process

Identify pre-entry activities, types of entries, and evaluation of entries. Recognize types of import resources, examinations of products and ...

Hazard Communication

Identify hazardous chemical documentation and labeling. Recognize definitions used within HazCom. Identify best practices to use in the workplace ...

Laboratory Specimens for Clinical Research

Identify the rules and regulations that apply to laboratory samples. Recognize how a sponsor utilizes the services of a central laboratory and how a ...

Drug Safety & Adverse Event Reporting

Recognize key historical events that led to the current system of drug safety monitoring, identify the role of pre-clinical testing required as part ...

Import Operations 1: Background

Recognize how FDA ensures that imported products meet US public Health standards. Recognize differences between the regulation of domestic and ...

Benzene

Identify the risks of working with benzene. Recognize methods for monitoring benzene exposure. Recognize practices to prevent fires and spills in the ...

The Approval Process for New Medical Devices

Identify the major steps in new device development. Identify the required regulatory process for the US market. Identify the purpose and ...

Import Operations 3: Other Activities

Recognize how import filers participate in OASIS. Recognize how FDA identifies and removes violative imports from the US market. Identify how FDA ...

Medical Device Safety Reporting

Identify the regulatory requirements in the medical device clinical trial and postmarketing environments. Recognize device safety monitoring and ...

Fall Protection

Recognize the dangers of all falls. Recognize the greater dangers of falls from height. Recognize fall protection requirements that apply to any ...

Sterile Dosage Forms Introduction

Identify the requirements of sterile products. Identify the methods of aseptic production. Identify the cleanroom requirements.

Selecting and Managing Clinical Contract Research Organizations (CROs)

Identify the requirements for selecting CROs and other service providers. Identify the requirements for effectively managing CROs and other service ...

Ethical Review Boards

Recognize the key events that helped establish the ethical review system. Recognize the membership requirements of an IRB/IEC and the procedures ...

GCP/ICH Obligations of Sponsors, Monitors, and Investigators

Identify the specific obligations of sponsors, monitors, investigators, and their staff in protecting the rights and welfare of human subjects who ...

Implementing an Equipment Qualification Program

Identify the importance of equipment qualification. Recognize the GMP requirements for equipment qualification.

Environmental Control and Monitoring

Recognize the definition of environmental control and environmental monitoring. Recognize how cleanrooms are classified according to International ...

Orientation to GMP Compliance

Recognize regulations and their importance to your industry. Identify basic GMP requirements and your roles and responsibilities for compliance. ...

Handling a Product Recall

Recognize the definition of “product recall.” Recognize when a product recall is required. Recognize the impact of a product recall on a ...

GxPs

Recognize what practices comprise the GxP regulations. Recognize how these practices relate to each step in the development and manufacture of new ...

Writing Validation Protocols

Identify what validation protocols are. Identify the three types of qualifications and their properties. Recognize the key elements involved in ...

Basics of Cleanroom Operations

Recognize how cleanrooms are designed, validated, and operated.

Recruitment and Retention of Study Patients

Identify acceptable ethical and regulatory recruitment and retention methods that can be used for clinical research trials. Recognize key factors in ...

Aspects of Regulatory History

Recognize the historical events that brought about the regulatory requirements for conducting clinical trials. Identify the standards, ...

Clinical Trial Audits and Consequences of Non-Compliance

Identify the differences between a sponsor site audit and an FDA inspection. Recognize FDA standards for conducting and reporting clinical site ...

Overview of the Clinical Research Process

Identify what is entailed in the research process for new drug, biologic, and device products, including the documents submitted in order to gain ...

HIPAA -- The Impact On Clinical Research

Identify who is required to comply with HIPAA Privacy Rules. Recognize the roles of an institutional review board (IRB) and a privacy board (PB). ...

Obligations of Investigators in Conducting Medical Device Trials

Recognize the requirements for conducting medical device research including following a protocol, safety and reporting standards, and documentation ...

GCP/ICH Obligations of Sponsors and Monitors

Recognize the roles and responsibilities of sponsors and monitors in clinical trials. Identify regulatory requirements, the types of personnel ...

European Union Clinical Trials Directive

Identify the principal elements of the EU Clinical Trials Regulation and Good Clinical Practice Directive.