EXTERNAL RESOURCES

Links To Compliance Resources On The Internet

Category	Title	Description	Resource
PHARMACEUTICAL	ICH	Quality - Pharmaceutical	http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
PHARMACEUTICAL	FDA - Pharmaceutical Quality/Manufacturing Standards (CGMP)	Quality -Pharmaceutical	https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
PIPELINE SAFETY	API RP 1173	Pipeline Safety Management Systems	http://www.api.org/~/media/files/publications/whats%20new/1173_e1%20pa.pdf
PRIVACY	AICPA/CICA Privacy Maturity Model	Privacy Maturity model based on Generally Accepted Privacy Principles and the Capability Maturity Model (CMM). The PMM provides entities an effective means of assessing their privacy program against a recognized maturity model and has the added advantage of identifying the next steps required to move the privacy program in a positive direction.	https://vvena.nl/wp-content/uploads/2018/04/aicpa_cica_privacy_maturity_model.pdf
PROCESS SAFETY	Management of Change – what does a ‘good’ system look like?	The process industries have a history littered with the consequences of not managing change carefully and safely. Despite these lessons and a great deal of good practice, globally we continue to struggle to get it right. As time passes, our memories of the human tragedies linked to Flixborough (a temporary change) and Hickson & Welch (a series of non-assessed changes) fade and fall out of our common experience. However, we still need to learn the lessons – properly – and ensure that they are embedded in our industries’ everyday practice.	https://www.icheme.org/media/11514/lpb267_pg07.pdf
PROCESS SAFETY	OSHA 1910	Occupational Health and Safety	https://www.gpo.gov/fdsys/granule/CFR-2013-title29-vol5/CFR-2013-title29-vol5-part1910
PROGRAM MANAGEMENT	Exploring program management competences for various program types	This paper challenges the implicit;one-size-fits-all; assumption that dominates mainstream program management competence literature. Findings from case studies of ten programs executed in a large pharmaceutical company suggest that different programs require different competences of program managers. Based on the Pellegrinelli (1997) program typology we put forward a framework, linking specific management competences to program types. By establishing the link between the program typologies literature and program management competence literature, the paper shows that programs should not be treated as a generic and homogenous category in discussions on program management competences. In addition, the findings highlight program content as a significant contingency variable for understanding program management dynamics. The paper suggests a conceptual framework that combines program types with program management competence profiles that could be applied to appointment decisions, staff assessments and organizational development.	https://www.researchgate.net/publication/281606984_Exploring_program_management_competences_for_various_program_types
QUALITY	ISO 9000	Quality	https://www.iso.org/iso-9001-quality-management.html
REGULATION	Designing Safety Regulations for High-Hazard Industries	Safety Regulatory Designs	https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/technical-resources/hazmat-technical-resources/70131/designing-safety-regulations-high-hazard-industries.pdf
REGULATION	Petroleum Safety Authority (Norway)	HSE Petroleum Industry	http://www.ptil.no/?lang=en_US

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