This document outlines reasons for being alert to potential workplace hazards and how unsafe conduct can affect safety. It emphasizes the importance of following procedures, reporting all accidents and potential hazards to the appropriate person. This allows them to properly evaluate risks, ensure safety compliance, and keep accurate records that can help identify risks and prevent future accidents. Unsafe behaviors like illegal drug use, failing to follow rules or report issues can endanger one's own and others' health and safety.
This slide is prepared based on fact data worldwide and also who . and it helps to course study for bachelor of pharmacy and health undergraduates degree subjects.
This slide is prepared based on fact data worldwide and also who . and it helps to course study for bachelor of pharmacy and health undergraduates degree subjects.
Pv day frankfurt june 2015 zittartz presentationpharmasol
Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations.
Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations.
Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow pharmacovigilance principles.
In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional pharmacovigilance activities of pharmaceutical companies.
Pv day frankfurt june 2015 zittartz presentationpharmasol
Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations.
Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations.
Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow pharmacovigilance principles.
In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional pharmacovigilance activities of pharmaceutical companies.
1. Information sheet2
Health and Safety at Work Internal Use Only
Cattani Unit 6
Date: 03 June 2015
From: ElisaCattani
Information sheet 2
Health and Safety at Work
2. Information sheet2
Health and Safety at Work Internal Use Only
Cattani Unit 6
REASONS BECAUSE IT IS IMPORTANT TO BE ALERT TO
POTENTIAL HAZARDS WHEN DEALING WITH
MACHINERY, EQUIPMENT AND SUBSTANCES SUCH AS
TONER AND FLUIDS
It isreasonable tobe alerthowmaterials/substances,equipment,machinery orbehaviourcanhurt
us because theyinterfere withourhealth,abilitytoworkandpersonal welfare.
As justsaid,handlingcorrectlythe equipmentpreventillness,dangertohealthorlossof life.
Inhalationof toxicfumescancause lungproblems,illnessordizziness.Liquids(chemical) ortoners
may containacidswitchintrude intooursystemandalter its correct functions.Youcanhave many
symptomsusingimproperlyyourequipmentfromlacerationsandcutstoback problems,from losing
your visionto some limbs.Moreover,personal choicesasnotfollowingbreaksduringthe workhours
can bringto the same resultasexplainedlater.
HOW UNSAFE PERSONAL CONDUCT (EXAMPLES
NEEDED) COULD EFFECT THE WORK
Under the unsafe personal conduct,the employee canbe a factor in decrease his/hersafetyandthe
others’one when:
- Consumes(neverthelessif before/aftershift),distributesorpossessesillegal drugsand
alcohol;
- Createsor contributestoputindisorder,promotesunhealthyorriskierworkingconditions
- Failsto followwithprocedures,rulesandregulationssetbythe law andappliedbythe
company
- Failsto reportall accidentsandinjuries orunsafe conditionsandpractices
- Smokes(ordisposesinappropriatelyof smokingmaterials)inunauthorized area
appropriatelylabelled.
3. Information sheet2
Health and Safety at Work Internal Use Only
Cattani Unit 6
IMPORTANCE TO REPORT ACCIDENTS AND POTENTIAL
HAZARDS TO THE APPROPRIATE PERSON
Everyorganisationhasgot,by law,a responsibleinH&Sproceduresbecause ithasbeenrequiredby
the law.
The importance to reportaccidentsandpotential hazardstothe appropriate personlaysonthe
liabilityof bothpeople if somethingoccursbecause the law dictatesthatanyone isresponsible to
preventaccidentsfrompotentialhazards within theirrole andresponsibilities. Moreover, the
appropriate person hasgotthe competencies toevaluate if the riskislikelytohappen,estimate the
seriousnessof the probable injuryandcanaskthe organisationtoputinset safetyprocedure in
orderto complywiththe legislation.
The report of an accidentallowstokeepanaccurate record of what happenedandwasdone inthe
case of litigation.Itshouldcontainthe conditionof the site orpremises,ratherthanthe machinery,
plant,substancesorequipmentusedwhere the accidenthappened.Otherinformationneededis
whenhappened,whowasinvolvedandhow the workwasorganised,carried outor supervised.
Therefore,all these datacanhelpidentifyingwhereandhow risksarise andwhethertheyneedtobe
investigatedproducingabetterconsciousnessaboutthe risk.