Enhancing people and businesses

This course is certificated by the Chartered Quality Institute and International Register of Certificated Auditors (CQI/IRCA; Course Certification Number, 2428 - PR 369)This course consists of 10 VILT sessions and the final examination.Course Criteria - ObjectivesUpon completion of this course, learners will be able to:Explain the purpose of a medical device quality management system (MD QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standard, third-party certification, and the business benefits of the quality management system;Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system  in accordance with ISO 19011 (and ISO 17021 where appropriate);Plan, conduct, report and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.Prior knowledge Before starting this course, learners are expected to have the following prior knowledge:ISO 13485Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD QMS ISO 13485:2016 Foundation (FD 132) course or equivalent.Medical Device management System AuditThe Plan, Do, Check, Act (PDCA) cycle.The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.The process approach used in MD QMS.A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485.  This knowledge may be gained by successfully completing a CQI and IRCA course relating to individual regulatory authority standards, which will be available subject to demand (e.g. MD QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MRD) Practitioner - PT 219)A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971

Prerequisites:  Prior knowledge of GMP’s and HACCP, or experience with Food Safety Management Systems, is recommended.FSPCA requires each participant to have your webcam on during the duration of the training.This course developed by the FSPCA is the “standardized curriculum” recognized by FDA; successfully completing this course is one way to meet the requirements for a “preventive controls qualified individual.”The Current Good Manufacturing Practices, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food regulation) are intended to ensure safe manufacturing, processing, packing, and holding of food products for human consumption in the United States.

This workshop Analyses different ASPICE concepts with a focus on real-world automotive applications. Participants will gain insights into key topics of this standard. Also talks about SGS India’s AFSP program AFSE program. Ideal for engineers looking to build or accelerate their careers in Automotive process.No prior knowledge required

ISO/IEC 27001 Lead Implementer training course enables participants to acquire the knowledge necessary to support an organization in effectively planning, implementing, managing, monitoring, and maintaining an information security management system (ISMS).Information security threats and attacks increase and improve constantly. The best form of defense against them is the proper implementation and management of information security controls and best practices. Information security is also a key expectation and requirement of customers, legislators, and other interested parties.This training course is designed to prepare participants in implementing an information security management system (ISMS) based on ISO/IEC 27001. It aims to provide a comprehensive understanding of the best practices of an ISMS and a framework for its continual management and improvement.By enrolling on this course you agree to your personal information being passed to PECB.CertificationAfter successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certified ISO/IEC 27001 Provisional ImplementerPECB Certified ISO/IEC 27001 ImplementerPECB Certified ISO/IEC 27001 Lead ImplementerPECB Certified ISO/IEC 27001 Senior Lead ImplementerGeneral informationParticipants will be provided with the training course material containing over 450 pages of explanatory information, examples, best practices, exercises, and quizzes.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 31 CPD (Continuing Professional Development) credits.In case candidates fail the exam, they can retake it within 12 months following the initial attempt for free.PrerequisitesThe main requirement for participating in this training course is having a general knowledge of the ISMS concepts and ISO/IEC 27001.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF)

ISO/IEC 42001 Lead Auditor training course enables you to gain the necessary expertise to audit artificial intelligence management systems (AIMS) by applying widely recognized audit principles, procedures, and techniques.Artificial intelligence (AI) has become integral to the success of many organizations by enhancing efficiency through automation and improving decision-making by utilizing advanced data analytics. However, organizations should ensure the appropriate and ethical use of AI. ISO/IEC 42001 enables organizations to implement appropriate processes and controls to ensure the responsible use and management of AI system.As the number of organizations seeking ISO/IEC 42001 compliance increases, there is a simultaneous surge in demand for skilled auditors possessing the necessary knowledge to assess and verify compliance. Therefore, PECB has developed the ISO/IEC 42001 Lead Auditor training course to empower participants with the knowledge and skills essential for planning and conducting ISO/IEC 42001 audits based on best audit practices.The ISO/IEC 42001 Lead Auditor training course is beneficial for professionals seeking to stay ahead of the competition. This training course equips you with the expertise needed to navigate the intricate realm of AI-influenced organizational frameworks, ensuring you are well-prepared to contribute to the success of organizations in this transformative era.By enrolling on this course you agree to your personal information being passed to PECB.CertificationAfter successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certified ISO/IEC 42001 Provisional AuditorPECB Certified ISO/IEC 42001 AuditorPECB Certified ISO/IEC 42001 Lead AuditorPECB Certified ISO/IEC 42001 Senior Lead AuditorGeneral informationParticipants will be provided with the training course material containing over 450 pages of explanatory information, examples, best practices, exercises, and quizzes.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 31 CPD (Continuing Professional Development) credits..In case candidates fail the exam, they can retake it within 12 months following the initial attempt for free.PrerequisitesThe main requirement for participating in this training course is having a fundamental understanding of ISO/IEC 42001 and AI principles and concepts.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF)

This highly participative training course provides an introduction and overview of Food Defence and explores guidelines, legal requirements and standards in use alongside GFSI expectations. The course explores authenticity plans to help map your supply chain and the importance of Food Defence plans.

This training provides participants with a quality system for warehouse and distribution processes dedicated for medicines.GDP demonstrates that organisations are committed to quality in every aspect of their service to their customers and the pharmaceutical industry.The GDP training provides an introduction to Good Distribution Practices (GDP) for the pharmaceutical industry and its role in ensuring the safety of pharmaceutical products when in transportation or storage. Complying with the GDP requirements is proof that organisations are able to deliver good quality products, as intended by the pharmaceutical manufacturers, thereby serving the healthcare sector as a vital partner of the healthcare supply chain.The regulatory and legislative GDP guidance have a large impact on the manufacture of pharmaceutical products. This training offers participants the opportunity to share and discuss GDP guidance and experiences relevant for drug manufacturers industry with colleagues and industry experts.

The objective of this course is to provide you with an understanding of the concept of TISAX® and an overview of the purpose and requirements of TISAX® as a tool for business improvement.Course Content:Overview, including why TISAX® is important Requirements and the structure of TISAX® How to start and execute a TISAX® project TISAX® processes and procedures TISAX® Quiz

Upon completion of this course, learners will be able to :Understand the potential range of social issues and ethical issues that is faced by the  organizations and auditors; and the range of conventions, specifications, codes of conduct and other initiatives.Explain the role of an auditor to plan, conduct, report and follow-up a social system audit in accordance with ISO 19011.Plan, conduct, report and follow-up a social system audit in accordance with ISO 19011 and by interpreting the requirements of Social Systems.Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.The 5-days course will be divided into 12 sessions that would focus on :Background of social systems, introduction to relevant legislation and activitiesAccreditation, certification and auditor competence. Planning the audit and activities.Preparing for an audit. Conducting the stage 1 audit and activitiesConducting stage 2 audit and activitiesInterpretation of Social Systems : Child and forced labor.Interpretation of Social Systems : Health and Safety. Freedom of association, discrimination and disciplinary practices.Interpretation of Social Systems : Working Hours and remuneration. Management SystemsAudit reviewReporting and  follow-upActivitiesFeedbackCase Studies

The purpose of this course is to equip the learners with the knowledge of the purpose and requirements of social systems and preparation for further auditor training. This course may be valuable as preparation for learners planning to complete other social systems-based training courses such as social systems auditor / lead auditor training course.MODULE ONE : OVERVIEW OF COURSE  Background 2 Social Accountability Workshop one ethical dilemmas and feedback . Overview of the standard requirements. Workshop 2 : Social Responsibility questionnaire and feedback. Auditors' personal characteristics and its implication on auditing. MODULE 2 RECAPITULATION The audit processes Workshop 3 : Audit evidence / audit trail Audit planning and preparation Workshop 4 : Audit plan Workshop 5 : Audit checklist next client conducting the on site audit Review report and addressing corrective actions Workshop 6: Reviewing and reporting on an audit.

The objective of this course is to provide learners with the knowledge and skills required to perform social accountability audits of an organisation’s conformance in accordance with ISO 19011. This course is recognised by APSCA for CPD purposes, aligned with the APSCA Competency Framework and is worth 40 CPD credits.Recommended Prior KnowledgeBefore starting the course, learners are expected to have knowledge of the following:- SA8000® Standard- Social Accountability International (SAI) Guidance for the SA8000® Standard- Ethical Trading Initiative (ETI) Base Code- The International Labour Organisation (ILO) Standards- UN Human Rights ResolutionsTrusted Social Accountability Lead Auditor training from a leading course providerOur courses are delivered by tutors who are environmental management system experts and experienced trainers. Your knowledge and skills will be developed through an interactive and practical approach to learning. Case study materials and role-play exercises are used to develop and practice skills in all phases of auditing. Participants are continually assessed and required to complete an end-of-course written examination.Course CertificationOn completion of this course:- Learners who attend the course in full and pass the examination will be issued with a 'Certificate of Achievement' that may satisfy part of the formal training for an individual seeking certification as a Lead Auditor.  Please refer to the relevant auditor certification body for specific requirements.- Learners who attend the full duration of the course will be issued with a 'Certificate of Attendance'.- Learners who fail the examination will be allowed to resit the examination a maximum of two times within 12 months of the end date of the course.