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.
The Accredited Persons (AP) Inspection Program allows for accredited persons to conduct the equivalent of an FDA quality system audit for manufacturers of FDA-regulated products. The accreditation is granted to third parties based on certain eligibility criteria and training. Manufacturers can opt for an accredited third party to inspect their facility when they meet the eligibility criteria...
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.
The Accredited Persons (AP) Inspection Program allows for accredited persons to conduct the equivalent of an FDA quality system audit for manufacturers of FDA-regulated products. The accreditation is granted to third parties based on certain eligibility criteria and training. Manufacturers can opt for an accredited third party to inspect their facility when they meet the eligibility criteria...
Pass Regulatory Affairs Certification In First Attempt
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Quality Systems and Good Machine Learning PracticesEMMAIntl
FDA expects every medical device manufacturer to have a robust and compliant quality system. FDA has been taking great strides in establishing regulations for the digital health industry that also facilitates research and development while maintaining high quality products...
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
7 Things about Pharmacy Billing and ReimbursementJessica Parker
Knowledge coupled with the right technology and a good monitoring system can leverage pharmacy billing to a profit bearing system that can lead to an effective Revenue Cycle Management (RCM) process. http://goo.gl/At6aiz
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.
Success comes from enabling your workforce to make better decisions and execute appropriate actions. We deliver value to your Hospital or Clinic by helping you reduce the time, resources, effort, and cost of operating your Laboratory System.
Our Laboratory Information System is built on world class Sage 300 ERP award winning architecture. Lab System integrates with any HL7 compliant hospital information system. LIS follows CAP compliant (College of American Pathologists) and most of the hospitals were LIS is implemented are JCI (Joint Commission International).
Learn how to create and maintain a Trial Master File for your site or clinical trial and what are the critical components of a TMF. Register for the webinar.
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
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.
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Healthcare App Testing - Make Your App FlawlessBugRaptors
We have almost entered in an era where applications monitor our lives. Starting from a primary BP machine to conventional angiography, we depend upon application and digital devices. This makes testing of healthcare mobile apps more crucial than ever. Check out the PPT to know more about healthcare app testing.
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
Quality Systems and Good Machine Learning PracticesEMMAIntl
FDA expects every medical device manufacturer to have a robust and compliant quality system. FDA has been taking great strides in establishing regulations for the digital health industry that also facilitates research and development while maintaining high quality products...
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
7 Things about Pharmacy Billing and ReimbursementJessica Parker
Knowledge coupled with the right technology and a good monitoring system can leverage pharmacy billing to a profit bearing system that can lead to an effective Revenue Cycle Management (RCM) process. http://goo.gl/At6aiz
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.
Success comes from enabling your workforce to make better decisions and execute appropriate actions. We deliver value to your Hospital or Clinic by helping you reduce the time, resources, effort, and cost of operating your Laboratory System.
Our Laboratory Information System is built on world class Sage 300 ERP award winning architecture. Lab System integrates with any HL7 compliant hospital information system. LIS follows CAP compliant (College of American Pathologists) and most of the hospitals were LIS is implemented are JCI (Joint Commission International).
Learn how to create and maintain a Trial Master File for your site or clinical trial and what are the critical components of a TMF. Register for the webinar.
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
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
Healthcare App Testing - Make Your App FlawlessBugRaptors
We have almost entered in an era where applications monitor our lives. Starting from a primary BP machine to conventional angiography, we depend upon application and digital devices. This makes testing of healthcare mobile apps more crucial than ever. Check out the PPT to know more about healthcare app testing.
Quality Assurance and Regulatory Compliance for Pharmaceutical Product, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgaum/Belagavi
Best practices for preparing for and surviving inspectionsMontrium
Inspections are the apex of the clinical trial. It is something that we prepare, plan for and ultimately dread for the entire duration of the study. Being inspection ready can take a significant burden off your clinical team, maximize time and get your product to market faster.
In our upcoming webinar, we will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and some key strategies to ensure your team has a successful inspection.
We will also dive deeper into some of the tools Montrium has developed that give your clinical teams an edge when it comes to surviving inspections, and providing your team greater oversight into eTMF completeness.
The Webinar will cover the following topics:
• Why is preparing for inspections important?
• What are some of the challenges organizations face when it comes to inspections?
• Why is it difficult to be inspection ready at all times?
• Best practices when preparing for an upcoming inspection
• How to survive the inspector
• Introduction to Montrium's eTMF
• Plus much more...
Safety & Regulatory Solutions for Small and Medium-sized Life Science Organiz...Covance
A key issue for small and medium-sized enterprises is the optimal utilization of their limited resources for moving their product pipeline through clinical development, and launching and marketing their approved product(s). This is further heightened as both clinical trials and post-marketing activities continue to grow in complexity and scope due to stringent regulatory pressures, patient involvement and globalization. Yet companies face overwhelming pressure to get their product to market as quickly as possible.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Best practices for preparing for and surviving inspectionsMadison Ramsay
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
Quality system regulation equipment and facilities controls subsystem.OnlineCompliance Panel
The FDA's Quality System Inspection Technique (QSIT) inspectional methodology "divides" the requirements for medical device manufacturers into seven subsystems; one of those is the Equipment and Facilities Controls subsystem. The purpose of the Equipment and Facilities Controls (E&FC) requirements of the Quality System Regulation (QSR) is to ensure that adequate equipment and facilities are available and maintained for manufacturers to produce and store devices that conform to their specifications and reduce the potential for contamination of those products.
This webinar will provide an explanation of the regulatory requirements for facilities and equipment that must be followed by medical device manufacturers in the manufacture and storage of their products, beginning with an overview of QSIT and an in-depth review of the elements included in E & FC.
Outline of the challenges in developing integrated multichannel (nurse, call centre and web) compliance programmes to support multiple sclerosis patients. Presentation given at numerous conferences in Europe and the USA during 2007. This version presented at EyeforPharma's Patient Compliance and Communications conference, Geneva, June, 2007.
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.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Similar to Essentials of the trial master file for pharmaceutical (20)
This HIPAA Privacy and Security Audits and Enforcement training will cover HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited. Documentation requirements, enforcement actions and how to prepare and respond to an audit will also be explored.
Excel spreadsheets how to ensure 21 cfr part 11 compliancecomplianceonline123
Learn to create a GxP compliant Excel spreadsheet application. Understand how to validate Excel spreadsheets with minimal documentation. Learn to configure Excel for audit trails, security features, and data entry verification.
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potentialcomplianceonline123
The webinar training on clean power plans and the smart grid’s role in compliance will discuss final 111(d) rule components under which smart grid capabilities will qualify.
What is a Free Trade Zone?
A free trade zone (FTZ)is a designated area that eliminates traditional trade barriers, such as tariffs, some kind of taxes and fees and minimizes bureaucratic
regulations.
The goal of a free trade zone is to enhance global market presence of the Country or location by attracting new business and foreign investments.
Tax-free trade zones generate foreign exchange through exports, and create economic value added.
Free, foreign, and export processing zones all fall under the umbrella of being free trade zones. Because these terms are confusingly similar, they are often used
interchangeably.
What is SEC?
The U.S. Securities and Exchange Commission (SEC) oversees the key participants in the securities world.
Concerned with promoting disclosure of important market information, maintaining fair dealing, and protecting against fraud.
Responsibilities include:
Interpret and enforce federal securities laws
Issue new rules and amend existing rules
Oversee inspection of securities firms, brokers, investment advisers and ratings agencies
Oversee private regulatory organizations in securities, accounting, auditing fields
Coordinate U.S. securities regulation with federal, state, and foreign authorities
SEC Organization:
Division of Corporate Finance:Reviews documents required to be filed with the Commission
Division of Trading: Assists in maintaining fair, orderly and efficient markets.
Division of Investment Management: Maintains oversight of America’s $26T investment management industry
Division of Enforcement: Recommends commencement of investigations of SEC law violations
Division of Economic and Risk Analysis: Integrates robust economic analysis and data analytics
Laws Governing SEC:
Securities Act of 1933
Securities Exchange Act of 1934
Trust Indenture Act of 1939
Investment Company Act of 1940
Investment Advisers Act of 1940
Sarbanes-Oxley Act of 2002
Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010
Jumpstart Our Business Startups Act of 2012
SEC Reports:
8k - A report of unscheduled material events or corporate changes at a company that could be of importance to the shareholders or SEC
10k - Comprehensive summary report of a company's performance. Submitted annually to the SEC
10Q - A comprehensive report of a company's performance that must be submitted quarterly by all public companies to SEC. In10-Q, firms are required to disclose relevant information regarding their financial position.
18K - Use to update the SEC and investors regarding the status of a domestically traded foreign security and its issuer.
20F - A form issued by the SEC that must be submitted by all "foreign private issuers" that have listed equity shares on exchanges in the U.S.
SEC Investigations:
Can be triggered in many ways
Investigation is not the same as prosecution
Investigations involve fact finding and are usually not public
During an investigation, neither the staff nor the Commission makes any determination of wrongdoing
Following investigation, SEC staff present findings to the Commission
Commission can authorize the staff to file a case in federal court or bring an administrative action.
What Constitutes a GRC Program?
Governance, risk and compliance or GRC programs are complex – an organization has to use its GRC program to address the regulatory requirements expected of, among
others, the following:
Enterprise Risk Management
COSO Internal Controls
Environmental Compliance (EPA rules)
Anti Trust
Anti Money Laundering
Anti Bribery/Corruption
Quality Management and Standards such as ISO 9000, 9001
Process Management such as Six Sigma
Anti Harassment
Human Capital
Whistle-blowing
HR Processes
The areas listed above are just few of those that come under the purview of a robust GRC program.
Why Audit a GRC Program?
Given the complex nature of regulations around the world today and the increasing risks of doing business, it is important that the GRC program in an organization is
audited frequently. Most of the lapses in corporate governance occur due to outdated GRC programs that have not been audited and updated to reflect the current
regulatory environment.
Internal audits of GRC programs allow management and the board to identify risks and areas that need strengthening and root out any non-compliance.
An audit can help evaluate the adequacy of the program’s design and effectiveness as well as new practices and technologies to be implemented.
Audits of the GRC program have to be carried out periodically – these should supplement an ongoing, daily evaluation of the effectiveness of the program, including
monitoring of controls and responses.
Internal Audit Process – The General Steps:
Define evaluation scope, objectives, and the type of evaluation.
Define the level and type of assurance
Identify the evaluation team and skills required.
Develop evaluation plan.
Perform design adequacy evaluation.
Perform operational effectiveness evaluation.
Communicate evaluation results and ensure follow-up to address issues.
This quick reference guide discusses the anti-money laundering requirements for non-bank financial institutions including for Money Services Business (MSB).
What is Workplace Harassment?
Harassment is any unwelcome verbal or physical conduct based on protected bases (race, color, religion, sex, national origin, age, disability, retaliation, and sexual orientation) when:
The conduct culminates in a tangible employment action, or
The conduct was sufficiently severe or pervasive to create a hostile work environment.
How to Determine Harassment Exists?
To determine whether the harassment exists:
Evaluate frequency and severity of misconduct
Apply reasonable person standard
Would a reasonable person find the behavior hostile, intimidating or abusive?
Tangible effect on job not necessary
Psychological harm not necessary
What is Sexual Harassment?
EEOC defines sexual harassment as:
Unwelcome sexual advances
Requests for sexual favors
Other verbal or physical conduct of a sexual nature
Two most common forms of sexual harassment are:
Quid pro quo harassment
Hostile work environment harassment
Who Can Be Involved in Harassment?
Those who commit, employees at all levels:
Manager
Co-worker
Customers
Vendors
Members of opposite sex, members of same sex, etc.
Those who are targeted:
Victims
Bystanders
Witnesses who are affected by the harassment
How to Prevent and Respond to Harassment?
Review and understand company harassment policy
Comply with Title VII of the Civil Rights Act, which prohibits harassment and discrimination
Know how and when to respond to harassment issues
Report harassment immediately
Essentials of the trial master file for pharmaceutical
1. Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device
and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for
My Program
This training on clinical compliance will focus on the requirements of trial master file (TMF) for
pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn
the best practices to ensure that the TMF is ready for inspection by the regulatory authority.
Why Should You Attend:
The large majority of NDA and many 510(k) submissions are not submitted to the regulatory
agencies in a timely manner due to issues with the Trial Master File (TMF). While clinical
operations usually leads TMF efforts, staff throughout the company have res ponsibilities as part
of the TMF, and the TMF cannot be closed until all members complete their required sections.
Members of Data Management, Biostatistics, Medical Writing, CMC, Legal Affairs, Regulatory
Affairs, Quality Assurance and others have documents or sections that they must complete and
should be well aware of those requirements and formats of those documents before the study
starts. These requirements are in effect whether it is a large, global Phase 3 study, a 10 subject
Phase 1 study or a laboratory-based diagnostics study. It is this TMF which will get reviewed
upon your submission and often by different reviewers not previously involved with your
program when the studies occurred. It is also this TMF which is open for regulatory agency
audits so it is important that you standardize what is and what is not in the TMF and the
method that is used to collect the documentation.
This webinar will focus on the required parts and order of the TMF based on the type of
investigational product, whether it is a pharmaceutical product, a medical device, or a
diagnostic product. Roles and responsibilities of each study team member regarding TMF
documentation requirements will also be discussed.
Areas Covered in the Webinar:
The required parts and order of the TMF, specific to each industry
How to perform continual quality assurance of the TMF to ensure early TMF closure
Specific roles and responsibilities of each study team member regarding TMF
documentation requirements
TMF storage and security requirements
How to choose a TMF format – paper vs electronic or digital
Common pitfalls in TMF documentation
What Regulatory Agencies are looking for during TMF review
2. Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Any role within the pharmaceutical, medical device or diagnostics clinical development
portion of a company who have responsibility in ensuring success of a clinical trial
Clinical Operations personnel
Data Management personnel
C-level and VP-level personnel
Regulatory Affairs
Quality Assurance
Legal Affairs
Biostatistics
For More details visit us at:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703210?
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