Drug and Alcohol use and misuse at work has significant safety threats to a company's employees, customers and reputation.
See More: https://www.flyingmedicine.uk/drug-alcohol-testing-occupational
Awareness about safety working condition and to lessen the impact of Drug Abuse in work place gives rise to growing drug tests conducted by Employers nowadays.
Depending on the type of job, illicit drug use can impact job performance and the lives of other people
Stability Testing of Pharmaceuticals and SupplementsEMMAIntl
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability testing is required depending on the location of registration and agencies involved in its approval. Stability testing is the method of testing a product's safety, efficacy, and chemical composition after a set period...
This presentation was designed in conjunction with Construction Industry Federation (CIF) Ireland to present to its members on the dangers of substance misuse in the construction industry in Ireland, and how workplace testing can have a positive impact on the issue.
A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
Active pharmaceutical ingredients (APIs) are the core components of drugs that provide the desired medicinal effects. APIs are manufactured through chemical and physical processes from raw materials by pharmaceutical companies. This involves converting materials into APIs through sophisticated chemical synthesis, extraction, or fermentation processes. The production of APIs must be done safely, cost-effectively, and in an environmentally friendly manner to tightly control particle sizes and achieve narrow distribution for consistent results.
Providing the latest rules from Medical Council of India regarding how pharma companies can engage private doctors in India.
This is a topic causing a lot of confusion among doctors.
This document discusses prohibited substances in equestrian competition and the processes for detecting banned substances. It notes that all banned and controlled medications are prohibited to maintain a fair and level playing field. The FEI annually reviews the prohibited substances list and cautions against herbal therapies. An example is given of a winner being stripped of a title after testing positive for Reserpine. The processes of mass spectrometry for precise detection of molecules is described. Effects of caffeine on horses during exercise are shown to increase performance levels but also impact blood lactate, glucose, and insulin levels.
Pharmaceutical Regulatory Expectations for Complaint Handling; An Erosion to ...Obaid Ali / Roohi B. Obaid
This document discusses pharmaceutical regulatory expectations for complaint handling and improving quality systems. It addresses complaint handling as a GMP attribute and why quality cannot be ensured through testing alone. The document outlines key GMP elements and systems, including complaints and recalls, and emphasizes that GMP ensures drug quality, identity, purity and strength. It stresses learning from complaints and mistakes to gain insight and continuously improve systems. The presentation also analyzes two case studies on GMP tragedies to illustrate how issues were identified and addressed, and how similar problems can be avoided in the future.
Awareness about safety working condition and to lessen the impact of Drug Abuse in work place gives rise to growing drug tests conducted by Employers nowadays.
Depending on the type of job, illicit drug use can impact job performance and the lives of other people
Stability Testing of Pharmaceuticals and SupplementsEMMAIntl
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability testing is required depending on the location of registration and agencies involved in its approval. Stability testing is the method of testing a product's safety, efficacy, and chemical composition after a set period...
This presentation was designed in conjunction with Construction Industry Federation (CIF) Ireland to present to its members on the dangers of substance misuse in the construction industry in Ireland, and how workplace testing can have a positive impact on the issue.
A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
Active pharmaceutical ingredients (APIs) are the core components of drugs that provide the desired medicinal effects. APIs are manufactured through chemical and physical processes from raw materials by pharmaceutical companies. This involves converting materials into APIs through sophisticated chemical synthesis, extraction, or fermentation processes. The production of APIs must be done safely, cost-effectively, and in an environmentally friendly manner to tightly control particle sizes and achieve narrow distribution for consistent results.
Providing the latest rules from Medical Council of India regarding how pharma companies can engage private doctors in India.
This is a topic causing a lot of confusion among doctors.
This document discusses prohibited substances in equestrian competition and the processes for detecting banned substances. It notes that all banned and controlled medications are prohibited to maintain a fair and level playing field. The FEI annually reviews the prohibited substances list and cautions against herbal therapies. An example is given of a winner being stripped of a title after testing positive for Reserpine. The processes of mass spectrometry for precise detection of molecules is described. Effects of caffeine on horses during exercise are shown to increase performance levels but also impact blood lactate, glucose, and insulin levels.
Pharmaceutical Regulatory Expectations for Complaint Handling; An Erosion to ...Obaid Ali / Roohi B. Obaid
This document discusses pharmaceutical regulatory expectations for complaint handling and improving quality systems. It addresses complaint handling as a GMP attribute and why quality cannot be ensured through testing alone. The document outlines key GMP elements and systems, including complaints and recalls, and emphasizes that GMP ensures drug quality, identity, purity and strength. It stresses learning from complaints and mistakes to gain insight and continuously improve systems. The presentation also analyzes two case studies on GMP tragedies to illustrate how issues were identified and addressed, and how similar problems can be avoided in the future.
Drug Control in Racing (and other equine sports)Horse SA
by David Batty, Racing Analytical Services Laboratory
http://www.rasl.com.au/
Presented at the Horse SA 'Safer Horse Workplaces' 10 Nov 2016 at Mt, Barker South Australia.
http://www.horsesa.asn.au/ (search for equine workplace safety page)
Tigecycline Impurities Manufacturer and suppliers in India - Hemarsh Technologies was established in 2008 and since then our company has enjoyed a rapid growth. Our prime focus is on contract research and impurities synthesis for pharmaceutical industries.
The ICH Q3D Guideline for Elemental Impurities came into effect on January 2018 for all the products for human use. It is supplementary safety-based guidance for toxic impurities that added the existing ICH Q3C and ICH M7 as well as the existing guidelines for non-toxic impurities ICH Q3A and non-toxic degradants ICH Q3B.
However, it does not specify limit for the major components of drug products. This brings excipients in particular under examination, being they, unlike APIs, lack established daily doses.
Due to the low limits of elemental impurities there is requirement of most advanced instruments ICP-MS. The new guidance address not only the most toxic metals, but also a number of elements introduced intentionally, fetching the total number of elements are 24.
This document summarizes harm reduction strategies for chronic pain patients prescribed opioids. It discusses the opioid overdose epidemic and risk factors for overdose death such as high opioid doses, methadone use, and co-prescribing benzodiazepines. The document also outlines risk factors for opioid use disorder and provides case studies demonstrating strategies like identifying at-risk patients, using prescription drug monitoring programs, prescribing nasal naloxone, obtaining a DATA 2000 waiver to prescribe buprenorphine, and considering non-opioid alternatives.
This document provides harm reduction strategies for chronic pain patients who are at risk of opioid overdose or opioid use disorder. It discusses the opioid overdose epidemic, CDC guidelines, risk factors for overdose and addiction, and presents sample patient cases. For at-risk patients, it recommends strategies like prescribing nasal naloxone, considering buprenorphine treatment, using PDMPs to monitor prescribing, and lowering doses or changing medications if risks are identified. The goal is to continue providing pain relief while reducing risks of overdose or addiction.
This document provides harm reduction strategies for chronic pain patients who are at risk of opioid overdose or developing an opioid use disorder. It discusses the opioid overdose epidemic, CDC guidelines, risk factors for overdose like high dose opioids or combining opioids with benzodiazepines. It recommends identifying at-risk patients, using prescription drug monitoring programs, prescribing naloxone, considering buprenorphine treatment, and urine drug screening. Sample patient cases demonstrate how to apply these strategies, such as converting high dose opioids to lower doses or substituting buprenorphine for opioid addiction. Resources for additional help are also provided.
25 Years of Drug Testing and its Technical and Clinical FutureRiverMend Health
This document discusses the history and future of drug testing over the past 25 years. It notes that drug testing has increased from 12 million annual tests in 1992 to over 200 million now, with 15 million being mandatory. Testing can now be done via saliva, urine, or hair, each detecting drugs over different time periods. New technologies like instant urine tests and various drug testing kits are now used alongside traditional lab testing. The document outlines various drugs that are tested for like opioids, cocaine, and marijuana. It recommends best practices for drug testing including hair/saliva/urine screens, instant tests in treatment settings, varying the drugs tested, and using new technologies like LC/MS/MS.
This document summarizes the findings of a study by Oregon OSHA and CROET on the presence of formaldehyde in hair smoothing products. Laboratory analysis found that 37 samples of a "formaldehyde free" Brazilian Blowout product contained 6.8-11.8% formaldehyde on average. Additional Brazilian Blowout samples and some other products also tested positive for formaldehyde above OSHA limits. Air monitoring at salons found stylist exposures from 0.006-0.33 ppm on average during a single treatment, below OSHA limits but above more protective guidelines. The conclusion is that hair smoothing poses meaningful risks to stylists from formaldehyde, and products should be treated as such under OSHA regulations.
Hyderabad Laboratories Private Limited (HLPL) is a service providing organization based in Hyderabad, India that provides cost-effective chemistry solutions to pharmaceutical and chemical companies as well as academic researchers. HLPL uses experts to provide complex chemistry solutions like medicinal chemistry, custom synthesis, materials chemistry, and analytical services. HLPL's vision is to be a preferred global provider of quality research solutions to the pharmaceutical and chemical industries through dedicated efforts while protecting society and the environment.
Establishing a Practice Standard for Compounding Sterile Preparations in Phar...Andi Himyatul Hidayah
This document summarizes a chapter from the United States Pharmacopeia (USP) titled "Pharmaceutical Compounding - Sterile Preparations" (USP chapter 797). The chapter establishes practice standards for compounding sterile preparations in all healthcare settings. It defines sterile compounding and outlines responsibilities of compounding personnel. It also describes three levels (low, medium, high) of microbial contamination risk for compounded sterile preparations based on factors like cleanroom standards and complexity of procedures. The chapter aims to prevent patient harm from issues like microbial contamination during compounding of sterile preparations.
This document discusses drug testing in the workplace. It provides background on the history of drug testing in the US and Canada. It describes the common technologies used for alcohol and drug testing and notes limitations in their ability to determine impairment. The evidence for links between drug use and workplace accidents is reviewed, finding alcohol involvement in around 4-11% of accidents but inconclusive evidence for other drugs. Prevalence of alcohol and drug use in Alberta is outlined, finding alcohol the most commonly used substance but relatively low rates of problematic use.
Nextar is an outsourcing company located in Israel that provides integrated contract drug development and manufacturing services. They have over 35 employees working in state-of-the-art laboratories and clean rooms. Nextar has cGMP, GLP, ISO 13485, and ISO 9001 certifications. Their services include formulation development, analytical testing, custom chemical synthesis, and GMP manufacturing for clinical trials. They have successfully completed over 570 projects for 120 customers.
The document discusses alcohol and drug testing in the construction industry. It provides statistics on alcohol-related deaths and injuries in Western Australia. It promotes an alcohol and drug testing policy and program from Alcolizer Technology, discussing the benefits of testing, different testing methods, developing a policy, and the rights and obligations of employers and employees. Alcolizer Technology presents itself as a leader in alcohol and drug testing solutions, offering testing equipment, programs, training, and support.
This document analyzes FDA warning letters issued between 2007 and June 2014. It finds that warning letters increased 78% from 2007 to 2013, with pharmaceutical/biotech, medical devices, and food/beverage industries receiving 95.72% of letters. Recent decreases in letters are likely due to reduced FDA funding and inspection freezes. The document predicts letters will rise in 2015 with a proposed FDA budget increase.
10 Facts to pass the RAC (Regulatory Affairs Certification)pauljhon43
Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net
To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html
The concepts associated with risk managementDominic Parry
This document discusses the concepts of risk management in quality systems. It provides a brief history of risk management, noting its implicit role in GMP standards and more formal introduction in ICH Q9 and Q10 guidelines. It then outlines the risk management process, including steps like risk assessment, evaluation, control, and review. Various risk management tools are also introduced, such as Failure Mode and Effects Analysis and statistical process control charts. Throughout, it emphasizes applying a proactive, systematic approach to risk management to continually improve quality and protect patients.
Take a Breath, Look Back, See Around, Predict Future & Have a Dream to make D...Obaid Ali / Roohi B. Obaid
More than 400 participants represented dozens of manufacturing companies with diversified educational background & experience attended throughout the day with active participation in discussion forum of Regulatory & Quality Sciences.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
Gleamns reasonable suspicion training for supervisorMizFoster
This document provides guidance to supervisors on conducting reasonable suspicion and post-accident drug and alcohol testing according to FTA regulations. It discusses the signs of drug and alcohol impairment, when testing is required, and procedures for testing. Supervisors are trained to determine when reasonable suspicion or post-accident testing is needed and to ensure testing is conducted promptly according to requirements. The document aims to ensure testing determinations are made appropriately and procedures are followed correctly.
This presentation explains the benefits of performing drug tests on your employees. It also explains when to properly administer them to your work force.
Drug Control in Racing (and other equine sports)Horse SA
by David Batty, Racing Analytical Services Laboratory
http://www.rasl.com.au/
Presented at the Horse SA 'Safer Horse Workplaces' 10 Nov 2016 at Mt, Barker South Australia.
http://www.horsesa.asn.au/ (search for equine workplace safety page)
Tigecycline Impurities Manufacturer and suppliers in India - Hemarsh Technologies was established in 2008 and since then our company has enjoyed a rapid growth. Our prime focus is on contract research and impurities synthesis for pharmaceutical industries.
The ICH Q3D Guideline for Elemental Impurities came into effect on January 2018 for all the products for human use. It is supplementary safety-based guidance for toxic impurities that added the existing ICH Q3C and ICH M7 as well as the existing guidelines for non-toxic impurities ICH Q3A and non-toxic degradants ICH Q3B.
However, it does not specify limit for the major components of drug products. This brings excipients in particular under examination, being they, unlike APIs, lack established daily doses.
Due to the low limits of elemental impurities there is requirement of most advanced instruments ICP-MS. The new guidance address not only the most toxic metals, but also a number of elements introduced intentionally, fetching the total number of elements are 24.
This document summarizes harm reduction strategies for chronic pain patients prescribed opioids. It discusses the opioid overdose epidemic and risk factors for overdose death such as high opioid doses, methadone use, and co-prescribing benzodiazepines. The document also outlines risk factors for opioid use disorder and provides case studies demonstrating strategies like identifying at-risk patients, using prescription drug monitoring programs, prescribing nasal naloxone, obtaining a DATA 2000 waiver to prescribe buprenorphine, and considering non-opioid alternatives.
This document provides harm reduction strategies for chronic pain patients who are at risk of opioid overdose or opioid use disorder. It discusses the opioid overdose epidemic, CDC guidelines, risk factors for overdose and addiction, and presents sample patient cases. For at-risk patients, it recommends strategies like prescribing nasal naloxone, considering buprenorphine treatment, using PDMPs to monitor prescribing, and lowering doses or changing medications if risks are identified. The goal is to continue providing pain relief while reducing risks of overdose or addiction.
This document provides harm reduction strategies for chronic pain patients who are at risk of opioid overdose or developing an opioid use disorder. It discusses the opioid overdose epidemic, CDC guidelines, risk factors for overdose like high dose opioids or combining opioids with benzodiazepines. It recommends identifying at-risk patients, using prescription drug monitoring programs, prescribing naloxone, considering buprenorphine treatment, and urine drug screening. Sample patient cases demonstrate how to apply these strategies, such as converting high dose opioids to lower doses or substituting buprenorphine for opioid addiction. Resources for additional help are also provided.
25 Years of Drug Testing and its Technical and Clinical FutureRiverMend Health
This document discusses the history and future of drug testing over the past 25 years. It notes that drug testing has increased from 12 million annual tests in 1992 to over 200 million now, with 15 million being mandatory. Testing can now be done via saliva, urine, or hair, each detecting drugs over different time periods. New technologies like instant urine tests and various drug testing kits are now used alongside traditional lab testing. The document outlines various drugs that are tested for like opioids, cocaine, and marijuana. It recommends best practices for drug testing including hair/saliva/urine screens, instant tests in treatment settings, varying the drugs tested, and using new technologies like LC/MS/MS.
This document summarizes the findings of a study by Oregon OSHA and CROET on the presence of formaldehyde in hair smoothing products. Laboratory analysis found that 37 samples of a "formaldehyde free" Brazilian Blowout product contained 6.8-11.8% formaldehyde on average. Additional Brazilian Blowout samples and some other products also tested positive for formaldehyde above OSHA limits. Air monitoring at salons found stylist exposures from 0.006-0.33 ppm on average during a single treatment, below OSHA limits but above more protective guidelines. The conclusion is that hair smoothing poses meaningful risks to stylists from formaldehyde, and products should be treated as such under OSHA regulations.
Hyderabad Laboratories Private Limited (HLPL) is a service providing organization based in Hyderabad, India that provides cost-effective chemistry solutions to pharmaceutical and chemical companies as well as academic researchers. HLPL uses experts to provide complex chemistry solutions like medicinal chemistry, custom synthesis, materials chemistry, and analytical services. HLPL's vision is to be a preferred global provider of quality research solutions to the pharmaceutical and chemical industries through dedicated efforts while protecting society and the environment.
Establishing a Practice Standard for Compounding Sterile Preparations in Phar...Andi Himyatul Hidayah
This document summarizes a chapter from the United States Pharmacopeia (USP) titled "Pharmaceutical Compounding - Sterile Preparations" (USP chapter 797). The chapter establishes practice standards for compounding sterile preparations in all healthcare settings. It defines sterile compounding and outlines responsibilities of compounding personnel. It also describes three levels (low, medium, high) of microbial contamination risk for compounded sterile preparations based on factors like cleanroom standards and complexity of procedures. The chapter aims to prevent patient harm from issues like microbial contamination during compounding of sterile preparations.
This document discusses drug testing in the workplace. It provides background on the history of drug testing in the US and Canada. It describes the common technologies used for alcohol and drug testing and notes limitations in their ability to determine impairment. The evidence for links between drug use and workplace accidents is reviewed, finding alcohol involvement in around 4-11% of accidents but inconclusive evidence for other drugs. Prevalence of alcohol and drug use in Alberta is outlined, finding alcohol the most commonly used substance but relatively low rates of problematic use.
Nextar is an outsourcing company located in Israel that provides integrated contract drug development and manufacturing services. They have over 35 employees working in state-of-the-art laboratories and clean rooms. Nextar has cGMP, GLP, ISO 13485, and ISO 9001 certifications. Their services include formulation development, analytical testing, custom chemical synthesis, and GMP manufacturing for clinical trials. They have successfully completed over 570 projects for 120 customers.
The document discusses alcohol and drug testing in the construction industry. It provides statistics on alcohol-related deaths and injuries in Western Australia. It promotes an alcohol and drug testing policy and program from Alcolizer Technology, discussing the benefits of testing, different testing methods, developing a policy, and the rights and obligations of employers and employees. Alcolizer Technology presents itself as a leader in alcohol and drug testing solutions, offering testing equipment, programs, training, and support.
This document analyzes FDA warning letters issued between 2007 and June 2014. It finds that warning letters increased 78% from 2007 to 2013, with pharmaceutical/biotech, medical devices, and food/beverage industries receiving 95.72% of letters. Recent decreases in letters are likely due to reduced FDA funding and inspection freezes. The document predicts letters will rise in 2015 with a proposed FDA budget increase.
10 Facts to pass the RAC (Regulatory Affairs Certification)pauljhon43
Pass RAC (Regulatory Affairs Certification) in first attempt By the help of Exams4sure.net
To Get Complete File http://www.exams4sure.net/raps/rac-gs-exam-questions-dumps.html
The concepts associated with risk managementDominic Parry
This document discusses the concepts of risk management in quality systems. It provides a brief history of risk management, noting its implicit role in GMP standards and more formal introduction in ICH Q9 and Q10 guidelines. It then outlines the risk management process, including steps like risk assessment, evaluation, control, and review. Various risk management tools are also introduced, such as Failure Mode and Effects Analysis and statistical process control charts. Throughout, it emphasizes applying a proactive, systematic approach to risk management to continually improve quality and protect patients.
Take a Breath, Look Back, See Around, Predict Future & Have a Dream to make D...Obaid Ali / Roohi B. Obaid
More than 400 participants represented dozens of manufacturing companies with diversified educational background & experience attended throughout the day with active participation in discussion forum of Regulatory & Quality Sciences.
The document discusses the need for medical device manufacturers to comply with ISO 13485:2003 quality standards. It notes that situations like Medtronic paying $268 million to settle lawsuits over faulty defibrillator leads emphasize the importance of standards to ensure quality and manage risk. ISO 13485:2003 provides requirements for a quality management system to consistently meet customer and regulatory requirements. It shifts the focus from end-of-production quality inspection to quality control throughout the production process. Following the standard helps manufacturers realize better quality, cost-effectiveness and time to market for their medical devices.
Gleamns reasonable suspicion training for supervisorMizFoster
This document provides guidance to supervisors on conducting reasonable suspicion and post-accident drug and alcohol testing according to FTA regulations. It discusses the signs of drug and alcohol impairment, when testing is required, and procedures for testing. Supervisors are trained to determine when reasonable suspicion or post-accident testing is needed and to ensure testing is conducted promptly according to requirements. The document aims to ensure testing determinations are made appropriately and procedures are followed correctly.
This presentation explains the benefits of performing drug tests on your employees. It also explains when to properly administer them to your work force.
Quest Diagnostics is a leading provider of diagnostic testing, information and services. It has received accreditation from several organizations for its facilities and programs. Through its Employer Solutions division, it offers pre-employment drug screening, background checks, employee health programs, and OSHA compliance testing to help employers maintain safety and productivity. These services include drug and health screening, biometric measurements, personalized reports, and aggregated statistics to identify risks and encourage healthy behaviors.
This document provides information about Medical Disposables, a company that supplies drug tests and infectious disease tests. It discusses the company's products like urine drug tests, hair drug tests, saliva drug tests, and tests for alcohol, nicotine, pregnancy, and infectious diseases. It also covers the company's CLIA waived drug testing procedures and protocols, potential markets, sales department policies and procedures, and medical equipment offered. The overall document provides an overview of Medical Disposables' testing product lines and operations.
Good Laboratory Practice (GLP) regulations were created by the FDA in 1978 to ensure the quality and integrity of nonclinical safety data from laboratories. GLP provides a framework for how nonclinical studies are planned, performed, monitored, recorded, and reported. They apply to safety studies of products that are regulated by the FDA and EPA, such as pharmaceuticals, pesticides, and industrial chemicals. GLP regulations have since been adopted internationally through the OECD and individual countries to harmonize standards globally.
David O'Halloran has over 15 years of experience in quality assurance and regulatory roles in the pharmaceutical industry. He has held positions such as Director of QA/QC, Quality Assurance Supervisor, and Quality Assurance Associate. He currently works as an independent quality and regulatory consultant helping companies obtain production licenses from Health Canada.
Company HSE for WC Welding Services 2014Chris Schmidt
The document is an occupational health and safety handbook for WC Welding Services Inc. that outlines the company's policies and procedures related to substance abuse, behavioral safety, personal protective equipment, emergency response, and various workplace hazards. It establishes a zero tolerance policy for drug and alcohol use. Employees must submit to drug screening and will be subject to disciplinary action or termination for a positive test. The handbook provides guidance on safety topics like lockout/tagout, electrical safety, fall protection, and confined space entry to help prevent injuries and protect worker health.
Webinar: What is Reasonable Suspicion Training and Why Should I Care? Lucas Kibby
http://cleanfleet.org/webinar-reasonable-suspicion/
What RST is supposed to do and achieve
- As with any drug testing program:
- To prevent the workplace injuries and employee harm
- To decrease costs associated with injuries, employee turnover, insurance, productivity issues, and absenteeism
- To protect workplace assets
- Gives company the eyes and ears throughout the workforce for safety (supervisors are front-line defense for workplace safety)
This document outlines Austin Engineering's policies and procedures regarding alcohol and drug testing. It discusses education for employees, circumstances for testing such as post-incident, random testing, and thresholds for positive results. It also describes procedures for confirmed positive tests, employee assistance, and return to work. The goal is to assist any employees struggling with substance use issues while ensuring workplace safety.
This document provides an overview of quality assurance, good manufacturing practices (GMP), and good laboratory practices (GLP). It defines each concept and outlines their key principles and goals. Quality assurance aims to ensure products meet the required quality standards and involves implementing GMP, GLP, and other quality control measures. GMP focuses on establishing processes to minimize risks like contamination during manufacturing. GLP provides a quality system for non-clinical health and safety studies to ensure they are properly planned, performed, documented and reported.
Post-marketing surveillance involves monitoring drug safety after market release. It identifies rare or long-term adverse effects not seen in clinical trials. Manufacturers must report serious adverse events to regulatory agencies. Outsourcing bioavailability and bioequivalence studies to contract research organizations allows companies to access expertise and resources while reducing costs and time to market. CROs conduct clinical trials, data analysis, and reporting according to Good Clinical Practice standards. Qualification of appropriate CROs involves assessing capabilities, infrastructure, compliance history, and collaboration effectiveness.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
Good Laboratory Practices (GLP) are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP aims to ensure study data accurately reflects results and is traceable. The regulations were established in response to discovered fraudulent activities and poor practices in toxicology labs in the 1970s. Facilities that do not comply with GLP standards risk disqualification, meaning they cannot conduct new studies or submit existing ones. Disqualified facilities can apply for reinstatement by demonstrating they will adhere to GLP procedures going forward.
Good Laboratory Practices (GLP) are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP aims to ensure study data accurately reflects results and is traceable. The regulations were established in response to discovered fraudulent activities and poor practices at toxicology labs in the 1970s. Facilities that do not comply with GLP standards risk disqualification, meaning they cannot conduct new studies or submit existing ones. Disqualified facilities can apply for reinstatement by demonstrating they will adhere to GLP procedures going forward.
This document provides an overview of urine drug testing (UDT) and the ToxPlus software and services. It discusses what UDT is, the main types of testing, why physicians should conduct UDT on patients, which substances can be tested for, who and when to test, the ToxPlus workflow process, online services provided, CLIA waiver requirements, and reimbursement options for UDT testing and review.
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014Sathish Vemula
This document summarizes a report from Health Canada on drug GMP inspections conducted in fiscal year 2013-2014. Some key details include:
- 428 domestic drug GMP inspections were conducted and 411 received compliant ratings. 13 foreign inspections and 12 were compliant.
- The most frequently cited regulatory sections were for quality control, manufacturing control, and records requirements.
- Most observations (99%) were rated Risk 2 or 3 in terms of potential risk to patients.
- Key priorities for the program in 2014-2015 include enhancing risk management and collaborating with international partners.
Jonathan K. Mentzer has over 25 years of experience in quality assurance and quality control roles. He has a proven track record of reducing customer complaints and internal quality issues through root cause analysis. His experience includes setting up quality systems, conducting audits, developing testing protocols, and ensuring regulatory compliance. Currently he works as a Quality Assurance Coordinator at Frutarom USA overseeing quality for multiple divisions.
Jonathan K. Mentzer has over 25 years of experience in quality assurance and quality control roles. He has a proven track record of reducing customer complaints and internal quality issues through root cause analysis. His experience includes setting up quality systems, conducting audits, developing testing protocols, and ensuring regulatory compliance. Currently he works as a Quality Assurance Coordinator at Frutarom USA overseeing quality for multiple divisions.
Jonathan K. Mentzer has over 25 years of experience in quality assurance and quality control roles. He has a proven track record of reducing customer complaints and internal quality issues through root cause analysis. His experience includes setting up quality systems, conducting audits, developing testing protocols, and ensuring regulatory compliance. Currently he works as a Quality Assurance Coordinator at Frutarom USA overseeing quality for multiple divisions.
Similar to Occupational drug and alcohol testing (20)
At FlyingMedicine we are able to undertake EASA Cabin Crew Medicals as Dr Nomy is designated as a Aeromedical Doctor for Transport Malta. As his stamp is European, the certificates are valid for any of the 27 EASA countries.
We love doing cabin crew medicals which is whey we have very high satisfaction rates from this attending our clinics. Dr Nomy has undertaken several thousand cabin crew medicals in his career.
Know more: https://www.flyingmedicine.uk/easa-cabin-crew-medical-attestation
Yellow fever describes the symptoms people get when they are affected by the Yellow Fever i.e their eyes become yellow (jaundiced) and they develop a high fever.
Know more: https://www.flyingmedicine.uk/yellowfever-vaccination
The team at Flying Medicine are training in Occupational Medicine from the Faculty in Occupational Medicine, London. They are well placed to undertake a variety of regulatory medical assessments and certificates
Know more: https://www.flyingmedicine.uk/occupationalhealthmedicals
We offer a SAME DAY Service and late night bookings for all our EASA Class Medicals. Dr. Nomy Ahmed is licensed to perform all classes of EASA medicals as a UK CAA Authorised Designated Aviation Medical Examiner (AME).
Know more:https://www.flyingmedicine.uk/class1-pilot-medicals-uk-caa
Dr Nomy Ahmed is licensed to perform all classes of EASA medicals as a UK CAA Authorised Designated Aviation Medical Examiner (AME).
Know more: https://www.flyingmedicine.uk/pilot-medicals
The team at Flying Medicine are happy to undertake a stress free, swift and professional Taxi/ Minicab Driver Medical.
Know more:https://www.flyingmedicine.uk/taxi-minicab-driver-medical
We offer a SAME DAY Service and late night bookings for all our EASA Class Medicals. Dr Nomy Ahmed is licensed to perform all classes of EASA medicals as a UK CAA Authorised Designated Aviation Medical Examiner (AME).
For more details visit: https://www.flyingmedicine.uk/drug-alcohol-testing-occupational
The team at Flying Medicine are training in Occupational Medicine from the Faculty in Occupational Medicine, London. They are well placed to undertake a variety of regulatory medical assessments and certificates.
Learn more at: https://www.flyingmedicine.uk/occupationalhealthmedicals
Here is a short whiteboard explainer video on how airline alcohol testing is usually undertaken. For more details visit: http://www.flyingmedicine.uk/occupationalhealthmedicals
We offer a SAME DAY Service and late night bookings for all our EASA Class Medicals.
Dr Nomy Ahmed is licensed to perform all classes of EASA medicals as a UK CAA Authorised Designated Aviation Medical Examiner (AME).
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
2. Drug and Alcohol use and misuse at work has significant
safety threats to a company's employees, customers and
reputation.
They are notoriously difficult to manage once it becomes
evident or are implied unless companies have strategies in
place from the outset.
The use of illicit and prescription drug use within work
places is rising.
This is causing concern amongst the business community and government departments.
www.flyingmedicine.uk
3. Organisations which have business critical and safety
critical roles need to have a variety of strategies in place
to manage these risks.
One such effective strategy is to have an established work
place Drug and Alcohol Testing process.
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4. The benefits of workplace drug and alcohol testing include
* Establishes a clear, ongoing and ambiguous company message that substance misuse is unacceptable
* Acts as a deterrent against substance misuse at work
* Acts to ensure employees confirm their prescription medications can be safely used whilst at work
* Rapidly answers questions related to suspicions of substance misuse at work
* Helps to answer whether short term, short notice sick leave relates to substance misuse
* Gives confidence to managers/ HR that employees returning to work are being appropriately and
safely monitored
* Protects the company reputation and mitigates against accusations of substance misuse in relation to
safely critical work and incidents
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5. Independent testing
We offer the ability to test for substances as part of a drug
and alcohol policy / programme independent to the
organisation thereby removing the implication of bias
Independent review of results
The results of any Drug and or Alcohol test should be
reviewed by a MRO ( Medical Review Officer) to check to
see if there is another reasonable explanation for the
results. We offer this service in conjunction with or separate
to our testing capabilities.
More information about the MRO review process can be accessed here
www.flyingmedicine.uk
6. Testing
Testing can be done rapidly on site via POCT ( Point of Care
Testing) and sent for verification at approved laboratories without
delays
When testing is needed
Testing as part of your HR Drug and Alcohol process is
usually done for the following scenarios
1) Pre-employment - To ensure steps are taken in not hiring those
taking , using, abusing illicit or psychoactive substances
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7. 2) Post Incident/ accident - To see whether psychoactive substances were involved in an incident/
accident
3) On suspicion of substance use/misuse- To answer whether someones change in behaviour, aggression
or the smell of alcohol in their breath related to psychoactive substance use.
4) Randomly- To ensure compliance to the Drug and Alcohol policy and to act as a deterrent against
illicit use.
5) Return to work/ Post rehabilitation- To ensure employees maintain their abstinence after returning to
work.
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8. Samples of testing
The usual method for testing is on
blood, urine (breath for alcohol) although hair
samples can be used and are a good way to look back
over a longer time period ( months)
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10. Alcohol
Alcohol levels
Liver Function Tests (LFTs)
Mean cell Volume ( MCV)
CDT
Phosphatidylethanol) PEth
Urine Ethyl Gluconaride (EtG)
Urine Ethyl Sulfate (EtS)
For verified results a GC/MS test needs to be done which added an additional 3 day turnaround time
The sample can be done with or without Chain of Custody
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11. Time scales
Onsite test - Same Day via a Point of Care Test ( POCT)
Lab test - 1-2 days on average
Verified GC/MS result 5-7 days
Packages
We offer various combinations of tests although specifics can be requested
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12. Urine based Occupational Drug and Alcohol Screening Fee with report £195
Alcohol
Amphetamines
Barbiturates
Benzodiazepine
Cannabinoids
Cocaine
Codeine
Dihydrocodeine
Ephedrine
MDMA
Methadone
Metamphetamines
Morphine
Why use FlyingMedicine Ltd- As CAA and FAA aeromedical examiners with extensive experienced in the
aviation sector, we understand regulations with regard to D+A testing and can ensure not only pilots but
other safety sensitive workers are checked appropriately.
For further information please contact us
www.flyingmedicine.uk
13. Contact Us
Address
Abbotts House,
198 Lower High Street,
Watford, Hertfordshire
United Kingdom, WD17 2FF
Phone: 0333 404 3232
Email: info@flyingmedicine.uk
Web: www.flyingmedicine.uk