GxP Training Content: Now Available Directly in ZenQMS

Define computer systems validation; Outline criteria for selecting systems to be validated and for initial estimation of the degree of validation required; Access important guidance documents by industry bodies and regulatory authorities; Identify the phases of the computer systems lifecycle and describe the activities that are performed in each phase; Describe considerations influencing validation strategy; Describe the principles of GAMP5, risk assessment, and risk management; Assess software suppliers and their products; Outline the contents of a validation plan

Describe the design, development and installation phase of projects to validate computerized systems; Describe the validation phase of such projects; Describe the operation and maintenance phase; Determine which systems to validate; Determine the amount of validation required, and the strategy to use

In this session we describe how to prepare for and initiate an Urgent Safety Restriction (USR) for a centrally authorized product and for a product authorized through the Mutual Recognition or Decentralized Procedure. We outline the 24-hour procedure for execution of an USR, and the follow-up actions required, in each case. Finally, we specify the requirements for a variation application following an USR

On completion of this module, you should be able to follow good practice in: Planning pharmacoepidemiological research; Collecting data in such research; Analyzing data from pharmacoepidemiological studies; Interpreting and communicating the results of such studies

In this session we outline regulatory requirements for risk management plans in regions that are major markets for medicinal products: Europe, the USA, and (in a brief sketch) Japan. We describe the structure, main components, and submission requirements for EU Risk Management Plans and US Risk Evaluation and Mitigation Strategies, and we sketch notable aspects of risk management requirements in Japan.

Identify methods of signal detection and discuss their limitations; Describe how to accumulate evidence on a causal association between a drug and an event; Specify factors that increase the priority assigned to a signal, and describe methods of further investigation; Discuss reassessment of benefit/risk balance in the light of a previously unexpected reaction to a product, and specify actions to minimize risk

 Although pharmacokinetic (PK) and pharmacodynamic (PD) studies are routinely carried out in nonclinical and clinical stages of drug development, their role is perhaps less well understood than it ought to be by those who are not specialists in the field. In addition, greater emphasis is being placed by regulators on the value of PK and PD data. Evidence of good practice in the execution of PK and PD studies, and sound understanding of the implications of their findings, are becoming increasingly important in drug registration. In this session we define PK and PD, outline the uses of PK and PD data in a drug development program, and give examples of how good practice in obtaining and interpreting PK and PD data can contribute to the minimization of risk for a drug.

Summarize the advantages, and how to counteract the main weakness, of the core design of choice for many pharmacokinetic and pharmacodynamic studies; Adopt good sampling practice; Discuss non-compartmental and compartmental data analysis; Describe the rationale and characteristics of studies in special populations; Describe how to carry out bioequivalence testing

Regulation and company organization</B> - Explains the rationale for modern drug safety / pharmacovigilance (PV) regulation and practice, describes international policy-making bodies and sources of regulatory guidance, and outlines company drug safety / PV organization, product safety databases and core safety information.

Explain, with examples, why drug safety monitoring / pharmacovigilance is necessary; Describe ways in which drug safety / pharmacovigilance is regulated nationally and internationally, and identify international policy-making bodies; Outline how drug safety/pharmacovigilance responsibilities are organized within pharmaceutical and biotechnology companies; Sketch how a product safety database is compiled, how a product's safety profile is assessed, and how safety information is included in documentation for regulatory authorities, healthcare professionals, and consumers;  Apply appropriate terms to describe different types of adverse effect; Specify requirements to report adverse reactions to regulators; Outline requirements for safety data and for risk management plans in applications for marketing approval; List tasks involved in monitoring adverse reactions to marketed products, and sketch how safety signals are detected and tested.; Identify factors that influence the evaluation of a product's benefit/risk balance, and list actions that may be taken in response to changes in the balance.

Identify sources of legal requirements, regulatory guidance, and other requirements for the conduct of clinical trials; Define reportable events and reactions in drug trials; Discuss criteria for causality, expectedness, and seriousness of events; Summarize investigators' responsibilities for reporting to sponsors and research ethics committees

In this session, we set out the legal and regulatory requirements for safety reporting under the EU Clinical Trials Regulation. We specify the responsibilities of investigators and those of sponsors. We distinguish those reports that must be submitted by sponsors to the EudraVigilance portal and those that must be submitted to the Clinical Trials Information System. We specify the format and terminology that must now be used, and we identify the tools and pathways for electronic submission. Finally, we outline significant differences in requirements under the Clinical Trials Directive.

What do we mean by data? What is data integrity? ALCOA and ALCOA+; Raw data and metadata; Transcription and transformation of data; Static and dynamic data; True copies; Archiving and retention; Validation of computerized systems; Data governance; Key questions to answer; Unacceptable practices; Regulators? responses to data integrity failings.

What do we mean by data? What is data integrity?  ALCOA, ALCOA+ and ALCOA++; Source data and metadata; Transcription and transformation of data; Static and dynamic data; Certified copies; Archiving and retention; Validation of computerized systems; Data governance; Safeguarding of blinding; Regulators? responses to data integrity failings

Specify criteria to determine which environments, computer systems, electronic records, and electronic signatures must comply with the regulation; Describe procedures and controls required by the regulation for electronic records and electronic signatures; Describe the consequences of the FDA's discretion in enforcing compliance with some of the provisions of the regulation

Explain the purpose of Good Laboratory Practice (GLP) and describe the development of the US GLP Regulation and the OECD Principles of GLP. Identify consequences of failure to comply with GLP. Specify GLP requirements for laboratory organization and the responsibilities of personnel. Specify GLP requirements for the planning and performance of studies. Specify GLP requirements for reporting of study results and the storage and retention of records and materials. Identify typical findings of regulatory inspections of laboratories 

Access guidelines and regulations relevant to G(QC)LP. Outline the role and elements of a laboratory quality system. Specify some basic laboratory safety practices. Identify key types of laboratory document and summaries their contents and relationships. Outline the management of reference standard substances and reagents. Specify good practices for data recording and record keeping. Describe how to handle out-of-specification conditions. Specify some good housekeeping rules for the laboratory, and outline the role of audits and inspections.

Identify guidelines and standards relevant to GCLP. Describe various elements of laboratory organization, including quality management, documentation, personnel, safety, equipment, and test materials. Outline the contents of an analytical plan, and identify important considerations in the management of samples. Contribute to method validation, performance verification, and quality control of examination processes. Follow guidance on the reporting of results and the storage of records. Discuss the roles of error management, audits, external quality assessment, certification and accreditation, and regulatory inspections

GMP... what and why:</B><BR> This session explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents which are the source of GMP rules. Finally it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.

 In this session we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company's quality management system.

Hygiene, cleaning, and sanitation: Prevention of contamination is one of the most important goals of GMP. Contamination of product is often difficult to detect, so GMP rules emphasize preventive measures, including: attention to personal health and hygiene, and the wearing of special clothing, by staff; and cleaning and sanitation of premises and equipment. In this session we set out the basics of GMP requirements in these vital areas.

Documentation and records: Comprehensive documentation of procedures, formulas, work instructions, and specifications, and thorough recording of batch data, are fundamental requirements of GMP. In this session, we explain why documentation is so important, identify different types of document required, and set out some simple rules for recording and correcting data.

his session outlines the process of drug development and manufacture, from the discovery of new molecules, through nonclinical studies and clinical trials, to marketing approval application, manufacturing scale-up and quality management, and pharmacovigilance.

Explain why Good Documentation Practice is important, and identify principles that underpin it. List the various types of documents used and explain their functions. Discuss how documents should be created and controlled. Specify requirements for record keeping and data integrity, including those for entering and correcting data<

Understand why cleaning and sanitation are so very important in preventing contamination of product. Adopt good practices in preparing for, carrying out, and recording the cleaning and sanitizing of premises and equipment.

Explain what a CAPA system is and describe how it operates in a company's Quality Management System. Describe how a typical CAPA procedure is carried out. Outline the purpose and practice of root cause analysis. Discuss the role of progress tracking, escalating, and trending of CAPA procedures.

This session explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents which are the source of GMP rules. Finally it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.

In this session we provide an introduction to work in the warehouse, in which we describe the kinds of goods that come in and go out and how they may be stored in a typical layout. We identify methods of segregating stock, and we set out seven main goals of Good Manufacturing Practice (GMP) for the warehouse. Finally, we mention a few types of document that are important to warehouse personnel.

In this session we explain what medical devices are and how they differ from medicinal products. We define various special categories of such devices. We identify basic principles of their regulation, including risk classification. We outline requirements for technical documentation, clinical data, and post-market surveillance and vigilance. Finally, we identify the major players in regulation.

The Biologics Price Competition and Innovation Act. Biosimilarity and interchangeability. Criteria for licensure as biosimilar. Exclusivity. Patent infringement issues. FDA guidance. The Biosimilar User Fee Act.

In this  course, we address issues specific to 505(b)(2) applications. We compare the various pathways and distinguish those circumstances appropriate for a 505(b)(2) NDA from those that are not. We identify particular characteristics of 505(b)(2) applications. We refer the learner to other available courses on NDAs and ANDAs for further details of requirements - for format, content, mode of submission, and FDA review - that are covered there.

In this session we discuss the role of natural antibodies and outline how the dream of creating 'magic bullets' to fight disease has been realized. We identify the structural components of antibodies and describe their actions. We distinguish types of monoclonal antibody by their non-human and human components. Finally, we sketch how some therapeutic mAbs can be linked to cell-killing agents to increase their effectiveness against cancer.

Explain why and how governments encourage the development of medicines for rare human diseases, and identify important sources of information. Specify incentives offered for the development of medicines for rare diseases in the USA and in Europe. State the criteria for orphan drug designation in the USA and in Europe. List the contents of an application for orphan designation in the USA and in Europe, describe how to make an application in each case, and outline the process of review by the regulatory authority. Outline the sponsor's obligations and options after orphan designation in the USA and in Europe

Explain the rationale for the CTD, and describe the ways in which it is used. Identify regional differences in regulatory requirements for information in a CTD-formatted submission. Describe the structure of the CTD. Access guidance on detailed structure and content of the CTD. Outline formatting requirements for a CTD dossier. Convert EU NTA and US NDA section codes and headings to their CTD equivalents.

An introduction to the Centralized Procedure. This session provides background information. It specifies the types of product for which the CP is mandatory and those for which it is optional. It discusses the types of Marketing Authorization Application, and characteristics of the application procedure.

Provide an overview of the MRP process. Describe the pre-submission and submission actions in relation to timeline deadlines. Specify the responsibilities of the Reference Member State (RMS), the Concerned Member States (CMSs) and the applicant.

An introduction to the Decentralized Procedure</B> - This session provides background information. It covers products for which the DCP can be used, the types of Marketing Authorization Application, and characteristics of the application procedure.

Describe the structure, requirements and functionality of the eCTD. Outline XML basics and the architecture of the eCTD. Discuss Document Type Definitions (DTDs) and schemas. Explain how to build an eCTD. Specify regional differences. Discuss life cycle and change management. List criteria that will make an electronic application technically valid. Initiate electronic transfer to a regulatory authority. Create, submit and maintain an eCTD dossier throughout the life of a drug product.

Describe the role and responsibilities of regulatory affairs within the pharmaceutical industry in both the EU and the USA. Identify the main legislative instruments relating to medicinal products in both the EU and USA. Understand the main phases of the drug development process and be aware of the regulatory requirements that apply. Describe the requirements for applications for marketing approval and the procedures to be followed in both the EU and USA. Identify post-marketing regulatory activities in both the EU and USA.

Discuss key quality issues in the manufacture of mAb-based products.  Discuss key issues in nonclinical studies of mAb-based products.  Discuss key issues in the clinical investigation and use of mAb-based products.  Identify specific considerations for radiolabeled mAb-based products. Identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA

List the criteria for therapeutic equivalence of drugs. Outline the types of patent classification for an ANDA submission.  Explain how to use the Orange Book in the development of a generic drug. Describe methods for determining bioequivalence of drug products. Outline the content and format requirements for an ANDA submission.  Describe the ANDA review and approval process. Outline the provisions of the Generic Drug User Fee Amendments and summarize their effects on generics sponsors.

 Summarize the content and format requirements for a New Drug Application. Outline the procedural requirements for an NDA submission to the FDA. Describe the role of the FDA in the NDA review and approval process. List the principal provisions available from the FDA for expedited drug development and review, and summarize the criteria that apply to them.

Define the concept of variations to marketing authorizations in the EEA. Identify which type of variation is appropriate for each kind of change to be made. Identify the documentation required to support the variation. Describe how to prepare and submit variation notifications or applications appropriate for each type of variation and route of regulatory approval, including options for grouping of variations and for work sharing of assessment.

In this session we describe the role of the BLA, define biological product, and outline the legal basis of the regulation of such products in the USA. We specify key criteria for licensure of biologics. We identify, by product type, the Centers within the US Food and Drug Administration (FDA) to which a BLA must be submitted for review and approval. We emphasise the importance of good communication between the agency and the sponsor of a BLA before submission. We set out the high-level structure of the electronic Common Technical Document, with which BLA submissions must comply.

Sales and marketing personnel need to understand the legal and regulatory requirements of Good Promotional Practices (GPP) that must be met when advertising and promoting prescription drugs in the USA. In addition, this module will be of particular benefit to regulatory affairs and legal personnel involved with aspects of marketing

Direct-to-consumer (DTC) advertising: The big picture , Information generally expected in DTC ads, Modified requirements for communications in print media, Omit some prescription information, Use consumer-friendly language.

Statutes and regulations. Regulatory and industry guidance. Anti-Kickback Statute. False Claims Act. Major settlements under FCA/AKS. Physician Payments Sunshine Act. Drug samples. Distribution of reprints and other publications. Detailing by sales representatives. Speaker programs. Third-party scientific and educational events. Medical advisory boards. Responding to unsolicited requests for off-label information. Gifts of educational or non-educational items</li><li>Assessment.

Avoid the pitfalls of: selective presentation of favorable information, broadening or inadequate representation of indications, use of out-of-date information, misuse of statistics, misleading juxtaposition of information, and misbranding of an investigational drug.

This session emphasizes the need to comply with regulatory requirements and guidance on validation, identifying important regulatory authorities and international collaborations. It identifies the phases of equipment qualification, describes the purpose of process validation in relation to process control, and defines important terms relevant to validation.

This session explains how to identify equipment, systems and services to which Operational Qualification (OQ) applies. It identifies typical responsibilities of company staff and vendors for OQ. It specifies prerequisites for OQ and describes steps in the OQ process. It identifies tests required of equipment, systems and services during OQ. The learner is shown how to develop, review and execute protocols that specify the tests required, and to write OQ reports.

Describe the purpose and scope of validation master plans, outline their typical structure and contents, and explain their importance to management. Contribute to the creation of project validation plans and protocols. Identify important validation documents, specify their interrelationships, and describe how they are created and maintained. Prepare and use validation schedules and resource plans, explain the basics of change control, and outline regulatory requirements for reporting and validating manufacturing changes.

Define commissioning and Installation Qualification activities and scope. Explain the purposes of, and differences between, commissioning and qualification. Determine qualification requirements based on an impact assessment. Prepare and execute IQ protocols. Describe requirements for the content and approval of IQ reports.

Define cleaning validation terminology, and explain regulatory requirements. Determine the scope of cleaning validation. Carry out and validate tests of cleanliness. Determine acceptance criteria. Develop and execute a cleaning validation protocol. Analyze and report cleaning validation results, and outline an ongoing cleaning and monitoring program.