Gather, collate and provide information & guidance to meet organisational compliance
Overview
This standard covers the competencies you need to provide information and guidance to meeting organisational compliance in the business and to ensure regulatory and site quality requirements are in place and in accordance to current best practices, including Good Manufacturing Practice (GMP) to maintain compliance.
You will be required to demonstrate that systems are able to gather information and guidance and ensure this information is available, delivered and used to meet organisational compliance ensure compliance to the appropriate regulators, site licenses, internal and external procedures for carrying out science operations within the business environments.
This standard has been developed for persons responsible for regulatory activities whilst working in the life science sector. You are responsible with other members of the regulatory and quality teams for ensuring that all operations and procedures are processed and maintained in line with appropriate data security, regulatory, site and product license requirements.
Performance criteria
You must be able to:
P1 determine the extent of the information and guidance required to support the regulatory compliance needs
P2 ensure the requirements for health, safety and security in the work environment are identified
P3 identify the legal, license and regulatory requirements relevant to your area of work responsibility
P4 work to and implement best practices including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
P5 identify the social , environmental and ethical responsibilities
P6 obtain accurate interpretations of legal and regulatory requirements fromspecialists in your area of work internal and external to the organization
P7 identify the organisation structure of accountability for legal, regulatory and quality responsibilities in your organization
P8 identify the risks involved in non-compliance or non-conformance to regulatory or license requirements
P9 provide accessible, up-to-date information to the organisation and appropriate teams to ensure compliance and regulatory needs are met
P10 agree organisational responsibilities with decision makers, key people and stakeholders and how they will be demonstrated
P11 develop clear and accessible plans for how your area of responsibility willcomply with its legal, regulatory and license requirements
P12 ensure that regulatory surveillance systems are developed to monitor and maintain regulatory compliance and license requirements
P13 evaluate information and feedback about how your area of work performs in complying with responsibilities
P14 provide information to decision makers about how your area of work complies with its responsibilities
P15 make recommendations about changes or improvements to regulatory and compliance systems or processes
P16 communicate feedback and reports on regulatory compliance information, including non-compliance data
Knowledge and Understanding
You need to know and understand:
K1 the European, UK and country specific legislation, statutory codes, standards, frameworks and guidance relevant to the legal, license and regulatory requirements relevant to your area of work
K2 how to use and apply best working practices including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
K3 how to identify, collect, analyse, measure and assess data
K4 how to promote your organisations legal and regulatory responsibilities
K5 the requirements of health, safety and security in the work environment
K6 the social, environmental and ethical responsibilities relevant to your area of work
K7 the organisation structure of accountability for legal, regulatory and quality responsibilities in your organization
K8 the compliance risks involved in work processes and the effects of non-compliance to regulatory or license requirements
K9 the organisations risk assessment process
K10 how to identify, collate and communicate information to the organisation and appropriate teams and stakeholders
K11 how to develop plans and instructions for your area of responsibility
K12 how develop systems to monitor and maintain regulatory compliance and license requirements
K13 how to develop or use systems to communication regulatory information and feedback in your area of work
K14 the organisations change management system
K15 improvement and problem solving techniques
K16 how to manage ethical dilemmas and conflicts resulting from promoting organisational responsibilities
K17 how to obtain accurate and timely reports of your organisations performance in complying with regulatory and license requirements
K18 how to develop strategies to ensure compliance
K19 how to manage and promote effective communication with colleagues, individuals and other stakeholders