Now you don’t need to take any stress about the RAC US Exam. We provide you real exam questions along with updated Test Engine. You can pass your exam in first attempt with 100% passing assurance and money back guarantee. Get amazing flat 15% discount on RAC US exam and pass your RAC US Dumps Exam. Visit us for more information and RAC US Exam Questions.
https://www.certs4you.com/raps/rac-us-dumps.html
Pass Regulatory Affairs Certification In First Attempt
Passing RAC exam is not difficult now.
Real Exam Questions Answers Available NOW!
RAC Past papers Dumps Available at Exams4sure.com
RAC practice test with 100% Accurate Answers.
RAC Study Guide with 100% Exam Passing Assurance With Money Back Guarantee.
Exams4sure is there with all your study problem solutions
Get Complete File From http://bit.ly/1MtxBrv
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
Now you don’t need to take any stress about the RAC US Exam. We provide you real exam questions along with updated Test Engine. You can pass your exam in first attempt with 100% passing assurance and money back guarantee. Get amazing flat 15% discount on RAC US exam and pass your RAC US Dumps Exam. Visit us for more information and RAC US Exam Questions.
https://www.certs4you.com/raps/rac-us-dumps.html
Pass Regulatory Affairs Certification In First Attempt
Passing RAC exam is not difficult now.
Real Exam Questions Answers Available NOW!
RAC Past papers Dumps Available at Exams4sure.com
RAC practice test with 100% Accurate Answers.
RAC Study Guide with 100% Exam Passing Assurance With Money Back Guarantee.
Exams4sure is there with all your study problem solutions
Get Complete File From http://bit.ly/1MtxBrv
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 presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Pharmacovigilance Consulting Services with SJ Pharma ConsultingSteve Jolley
SJ Pharma Consulting Inc. is a world leader in global pharmacovigilance compliance and drug safety. Our pharmacovigilance experts have more than three decades of experience in the industry and serve over 200 clients across the U.S., Europe, Japan, China and India. Through our industry-leading services, we help pharmacovigilance operations maintain compliance with the latest US and EU laws and regulations. Learn more about our pharmacovigilance consulting services.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
Are you ready to implement FDA Food Safety Modernization Act?Nikoo Arasteh
Food Modernization Act was signed into law on January 5th 2011. Related regulations are being written and will be enforced piece by piece. Companies will have between 2 to 4 years to complete implementation of required safety systems based on their operation size. This presentation shows what FSMA is about, who will be impacted and what the deadlines are for compliance.
Recent FSMA Updates and what the FDA Expects of YouTraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Can you handle the recent FSMA curveballs?
The FDA made a big splash when it issued a set of “re-proposed” food safety regulations under the Food Safety Modernization Act (FSMA), including regulations for Current Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-Based Preventative Controls (HARPC) for Human Food.
Two of the significant issues that the FDA is addressing are how product testing and supplier verification fit into FSMA’s requirement for food companies to verify that their preventative controls effectively and significantly minimize hazards at their facilities.
This webinar will provide an overview of FDA’s comments on these two topics and insight about the legal issues they may raise for food companies.
Further, the webinar will explore how the FDA expects you to implement FSMA, and what the FDA expects for firms to show they are in compliance.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
Pharmacovigilance Consulting Services with SJ Pharma ConsultingSteve Jolley
SJ Pharma Consulting Inc. is a world leader in global pharmacovigilance compliance and drug safety. Our pharmacovigilance experts have more than three decades of experience in the industry and serve over 200 clients across the U.S., Europe, Japan, China and India. Through our industry-leading services, we help pharmacovigilance operations maintain compliance with the latest US and EU laws and regulations. Learn more about our pharmacovigilance consulting services.
This presentation gives a overview of the new FDA draft guidance on Analytical Method Validation and compares it with the older version issued in the year 2000.
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
Are you ready to implement FDA Food Safety Modernization Act?Nikoo Arasteh
Food Modernization Act was signed into law on January 5th 2011. Related regulations are being written and will be enforced piece by piece. Companies will have between 2 to 4 years to complete implementation of required safety systems based on their operation size. This presentation shows what FSMA is about, who will be impacted and what the deadlines are for compliance.
Recent FSMA Updates and what the FDA Expects of YouTraceGains
If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you.
Can you handle the recent FSMA curveballs?
The FDA made a big splash when it issued a set of “re-proposed” food safety regulations under the Food Safety Modernization Act (FSMA), including regulations for Current Good Manufacturing Practices (GMPs) and Hazard Analysis and Risk-Based Preventative Controls (HARPC) for Human Food.
Two of the significant issues that the FDA is addressing are how product testing and supplier verification fit into FSMA’s requirement for food companies to verify that their preventative controls effectively and significantly minimize hazards at their facilities.
This webinar will provide an overview of FDA’s comments on these two topics and insight about the legal issues they may raise for food companies.
Further, the webinar will explore how the FDA expects you to implement FSMA, and what the FDA expects for firms to show they are in compliance.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
Environmental Monitoring describes the microbiological testing under- taken in order to detect changing trends of microbial counts and micro- flora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations.
Over the past decade, environmental monitoring has become more sophisticated in moving from random sampling, using an imaginary grid over the room and testing in each grid, to the current focus on risk assessment and the use of risk assessment tools to determine the most appropriate methods for environmental monitoring.
This presentation gives current trends in the application of risk assessment to the practice of environmental monitoring.
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
Effective Complaint Management: The Key to a Competitive Edge for Medical Dev...Cognizant
By establishing strong complaint management processes, medical device firms can make continuous improvements in patient safety, regulatory compliance and customer satisfaction.
Maetrics: The ROI of Good Quality & ComplianceGeneris
On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One.
Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit.
Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...Merck Life Sciences
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.merckmillipore.com/webinars
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
PET CT beginners Guide covers some of the underrepresented topics in PET CTMiadAlsulami
This lecture briefly covers some of the underrepresented topics in Molecular imaging with cases , such as:
- Primary pleural tumors and pleural metastases.
- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
- The role of FDG PET in NET.
Under Pressure : Kenneth Kruk's StrategyKenneth Kruk
Kenneth Kruk's story of transforming challenges into opportunities by leading successful medical record transitions and bridging scientific knowledge gaps during COVID-19.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
Chandrima Spa Ajman is one of the leading Massage Center in Ajman, which is open 24 hours exclusively for men. Being one of the most affordable Spa in Ajman, we offer Body to Body massage, Kerala Massage, Malayali Massage, Indian Massage, Pakistani Massage Russian massage, Thai massage, Swedish massage, Hot Stone Massage, Deep Tissue Massage, and many more. Indulge in the ultimate massage experience and book your appointment today. We are confident that you will leave our Massage spa feeling refreshed, rejuvenated, and ready to take on the world.
Visit : https://massagespaajman.com/
Call : 052 987 1315
KEY Points of Leicester travel clinic In London doc.docxNX Healthcare
In order to protect visitors' safety and wellbeing, Travel Clinic Leicester offers a wide range of travel-related health treatments, including individualized counseling and vaccines. Our team of medical experts specializes in getting people ready for international travel, with a particular emphasis on vaccines and health consultations to prevent travel-related illnesses. We provide a range of travel-related services, such as health concerns unique to a trip, prevention of malaria, and travel-related medical supplies. Our clinic is dedicated to providing top-notch care, keeping abreast of the most recent recommendations for vaccinations and travel health precautions. The goal of Travel Clinic Leicester is to keep you safe and well-rested no matter what kind of travel you choose—business, pleasure, or adventure.
INFECTION OF THE BRAIN -ENCEPHALITIS ( PPT)blessyjannu21
Neurological system includes brain and spinal cord. It plays an important role in functioning of our body. Encephalitis is the inflammation of the brain. Causes include viral infections, infections from insect bites or an autoimmune reaction that affects the brain. It can be life-threatening or cause long-term complications. Treatment varies, but most people require hospitalization so they can receive intensive treatment, including life support.
DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
Our mission is to provide a safe and supportive environment where our clients can receive the highest quality of care. We are dedicated to assisting our clients in reaching their objectives and improving their overall well-being. We prioritize our clients' needs and individualize treatment plans to ensure they receive tailored care. Our approach is rooted in evidence-based practices proven effective in treating addiction and mental health disorders.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
Stem Cell Solutions: Dr. David Greene's Path to Non-Surgical Cardiac CareDr. David Greene Arizona
Explore the groundbreaking work of Dr. David Greene, a pioneer in regenerative medicine, who is revolutionizing the field of cardiology through stem cell therapy in Arizona. This ppt delves into how Dr. Greene's innovative approach is providing non-surgical, effective treatments for heart disease, using the body's own cells to repair heart damage and improve patient outcomes. Learn about the science behind stem cell therapy, its benefits over traditional cardiac surgeries, and the promising future it holds for modern medicine. Join us as we uncover how Dr. Greene's commitment to stem cell research and therapy is setting new standards in healthcare and offering new hope to cardiac patients.
2. 2
Regulatory Trends- An Ongoing Struggle
In the Life Sciences Industry, the cost of non-compliance has been especially acute.
1,600
• Almost every major life sciences company
has been under a settlement action or
monetary penalty situation
• Even though adoption of technology and
approvals of NMEs and devices increased,
regulatory events of significance have
increased too.
• Industry is spending at least $34B per year
on external compliance software and
services alone (Grand View Research)
Product
Recalls
Warning
Letters
4. 4
Regulatory Trends- An Ongoing Struggle
MedicalDevicesPharma
• Since 2011, for the first time total number of 483
observations rose in 2015
• During 2011-15, more than 95% of total 483
observations cited Current Good Manufacturing
Practices for finished pharmaceuticals (cGMP, 21 CFR
Part 211) deficiencies
• In the medical device industry, 64% of the FDA Form
483’s issued in 2015 were due to quality system
deficiencies, mainly in Corrective and Preventive
Action (CAPA) and Production and Process Controls
(P&PC).
5. 5
Regulatory Trends- An Ongoing Struggle
Warning Letter Trends
• CDER and the Office of Prescription Drug
Promotion issued 47 warning letters in 2016, 52 in
2015 and 53 in 2014.
• In 2016, 15 warning letters issued by office of
manufacturing cited data integrity as major
concern.
6. 6
Causes of 483s within cGMP (Pharma)
978
872
731
606
751
695
661 649
557
681
580
551
525
431
546
523
462
424
384
421
422
366
346
326
351
283
264
221
157
224212
152
127
86
109
190
181 213
222
350
2011 2012 2013 2014 2015
Number of 483 Observations with cGMP Violations by Sub Parts
Records and Reports
Laboratory Controls
Production and process
controls
Organization and Personnel
Equipment
Control of Components and
drug product containers and
closures
Packaging and labeling control
Buildings and Facilities
7. 7
Major Reasons for Medical Device Recalls 2016
# General Description
Material that may split or break, Tip Separation
Defective Connectors, Leads, Seal Defects
Explosion Risk, Premature Discharge
Inconsistent, Invalid, Inaccurate readings
Inadequate Sterilization, Contamination QC Failure
Coating Separation, Coating Contamination
Sensor Signal Loss, Electrical Issues
Category
Material
Design Defects
Battery Issues
Inaccurate Test
Results
Sterilization /
Contamination
Coating
Electrical /
Signal Loss
* 39 Med. Device Recalls of 2016 - https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm480134.htm
NOTE: Major Cause of Recall Identified in the category.
9
9
7
6
3
3
2
8. 8
The Five Deadly Sins
%*
38
37
13
6
6
General Description
Rudimentary cGMP, release testing, cleaning, equipment maintenance, cross
contamination
Lack of Access control to computerized systems. Deletion, falsification,
manipulation. ‘Non-contemporaneous data’
Aseptic Techniques, compounding and conventional sterility assurance SOPs
Drug Substance/API repacking , relabeling, contract manufacturing deficiencies
Import Alert 99-32 (Not allowing for inspection)
Category
SOPs, Documents
Data Integrity
Sterility Assurance
Supply Chain
Delay/ Deny/ Limit/ Refuse
* Analyses of 52 Warning Letters issued by Office of Manufacturing Quality in 2016.
Data Courtesy of Ms. Paula Katz, OMQ US FDA
9. 9
Xybion Corporation’s Take
Mitigate 483 blues with Xybion’s secure cloud based solutions
for 21 CFR Part 11, GxP Compliance
Explore Xybion’s Digital Workplace Solution (DWS) For Today's Connected
Workforce
Learn more: https://www.xybion.com/total-compliance/
Call us: Sales @ 844 291 4430
Write to us: sales@xybion.com