This SOPs for Clinical Trials training will cover ICH-GCP and ISO 14155 requirements for SOPs. It will outline steps to effectively develop and maintain SOPs and manage risks to your clnical research operation, through their use.
Why Should You Attend:
Failure to establish, maintain and adhere to written SOPs for Clinical Trials, expose the organization to Regulatory actions. These actions include, but are not limited to, seizure, injunction and/or civil money penalties and might even result in project/s discontinuation.
SOPs that are not appropriately written might bear risks due to: deviations, use of unauthorized versions/copies, misinterpretation, non-acceptance, lack of availability and more.
This training will show how you can write effective SOPs that will benefit the organization’s clinical research operations and general management by ensuring quality, efficiency, compliance with applicable requirements, reliability, consistency, accountability, process control, proper internal communication, change implementation, conservation and controlled distribution of knowledge and more.
Learning Objectives:
Understanding the regulatory requirements for SOPs in clinical research. Learning how to effectively develop and maintain SOPs. Understanding the added value of well written SOPs to your risk management program.
Areas Covered in the Seminar:
- ICH-GCP and ISO 14155 requirements for SOPs.
- Management Responsibilities for the development, maintenance and compliance with SOPs.
- Inspection findings related to SOPs.
- Risk management through the use of SOPs.
- Required features of SOPs.
- SOPs samples/templates.
- Benefits of efficient development, maintenance and use of SOPs.
Who Will Benefit:
This webinar will provide valuable assistance to the following Pharma, Biotech and Medical Device companies' personnel:
- General Managers and Directors
- Quality Systems managers
- Quality Assurance managers and auditors
- Clinical Development and Project managers
- Clinical Team managers
- Regulatory Compliance Associates and Managers
- Principal Investigators
- Heads and Members of Ethics Committees/Independent Review Board
- Trainers
Instructor Profile:
Ornat Katzir , MSc., MHA, has over 15 years of experience in clinical research:
- CRA and GCP manager in a US international pharmaceutical company
- Sr.CRA, Principal CRA, Team manger and Local Associate Clinical Operations manager of a large US CRO
- Quality Management Systems Associate of a large US international CRO
- Independent Clinical Research Consultant, GCP auditor and trainer
She has hands on experience in various aspects of clinical research:
- Monitoring and management of all stages of clinical research
- Development and review and assessment of clinical research documents and tools (Protocols, Informed Consent Forms, Case Report Forms, Questionnaires etc.) for compliance with applicable standards and regulations
- Development, review and assessment of internal systems/processes, standard operating procedures and working practice documents for compliance with applicable standards and regulations
- Systems and process audits and development of methodology and tools for these audits/reviews
- Development and quality check of documents summarizing the requirements for clinical trials in specific regions/countries
- Conduct of sponsors, CROs, sites and vendors GCP Audits
- Training clinical research personnel (sponsor/CRO and research sites teams)
