World Conference Calendar

30578 Conferences

Health and Medicinerss


Understanding and Preparing for FDA's New Part 11 Inspection Program - Webinar By GlobalCompliancePanel

Understanding and Preparing for FDA's New Part 11 Inspection Program - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-25-2011 Last Day: 01-25-2011
Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry. Reference material for easy implementation: * 25 recent FDA Warning Letters with part 11 violations. * 15 Case Studies: Implementing Part…
Key Concepts in OSHA Recordkeeping – 2.5 hrs comprehensive webinar

Key Concepts in OSHA Recordkeeping – 2.5 hrs comprehensive webinar

Location: , United States
Category: Health and Medicine
Start Date: 01-25-2011
This OSHA Recordkeeping training will address the key concepts in understanding the OSHA recordkeeping analysis. This training will include hypothetical fact scenarios that present common recordkeeping issues encountered by facility record keepers. OSHA injury and illness recordkeeping compliance is a point of emphasis for OSHA, and the recordkeeping regulations are frequently cited by the Agency. This 2hrs and 30 minutes OSHA Recordkeeping webinar training will address those key concepts that must be understood for accurate OSHA recordkeeping. The presenter has audited hundreds of employers’ OSHA 300 Log recordkeeping practices, has defended OSHA recordkeeping citations, and is a frequent speaker on…
Defining and Managing Protocol Deviation/Violation/Exception - Webinar By GlobalCompliancePanel

Defining and Managing Protocol Deviation/Violation/Exception - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-26-2011 Last Day: 01-26-2011
Overview: As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various…
Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-26-2011 Last Day: 01-26-2011
Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach using common Excel- or Word-type PC applications programs that can be used immediately. Regular use of a few simple but powerful tools will virtually eliminate "fire fighting" in a new project. Regular use can contribute greatly to reduction of scheduling uncertainty, incomplete projects when time is…
Assessing FDA’s Proposed Changes to the 510(k) Process in 2011

Assessing FDA’s Proposed Changes to the 510(k) Process in 2011

Location: , United States
Category: Health and Medicine
Start Date: 01-26-2011
This 510(k) webinar will help you understand the proposed changes to 510(k) process in 2011 and the regulatory process of implementing it. This 520(k) webinar will address both sides of the proposed changes. We will discuss how the expected change will affect device makers in terms of additional cost, affect on number of devices cleared, what is the regulatory process for implementing the changes. We will also discuss what industry has to prepare for the statutory changes coming in 2011.
Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge - Medical Device Webinar By ComplianceOnline

Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge - Medical Device Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 01-27-2011 Last Day: 12-01-2010
This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system. Areas Covered in the Seminar: FDA and ISO requirements for complaint handling. Establishment of complaint handling program. What constitutes a complaint. ISO-specific implications of complaint handling. The roles of investigation and corrective action in complaint handling. Complaint trending and reporting. Application of risk management to complaint handling program. Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since complaint handling is a…
Ethics, Standards and Identifying Risks in Clinical Research - Clinical Compliance Webinar By ComplianceOnline

Ethics, Standards and Identifying Risks in Clinical Research - Clinical Compliance Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 01-27-2011 Last Day: 11-30-2010
This clinical research ethics training will impart an understanding to regulatory compliance and clinical study personnel on the importance of ethics in clinical research and impart a familiarity with the regulations to protect both the researcher and the subject. Areas Covered in the Seminar: Overview of the main ethical principles to be considered in the development and conduct of research to protect both the researcher and the subject. Responsibilities of Research sponsors Clinical researchers Institutional Review Boards (IRBs) Description of the standards and requirements of informed consent. The role of drug safety committees. Ethical and regulatory issues relating to Tissue…
Webinar on Pharmacovigilance Audit - Webinar By GlobalCompliancePanel

Webinar on Pharmacovigilance Audit - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-27-2011 Last Day: 01-27-2011
Overview: This webinar will describe how to conduct a thorough drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices. The course will cover all aspects of drug safety and pharmacovigilance compliance including the collection, assessment and reporting of adverse event cases, the analysis of cases to detect signals, the management of signals and safety concerns, and the development, execution and monitoring of risk management plans. Why should you attend: During high profile drug withdrawals of the past, most of…
Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 01-27-2011 Last Day: 01-27-2011
Overview: Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: * Become compliance when using Excel spreadsheets for GxP data. * Reduce validation time and costs. * Increase compliance while lowering resource needs. * Avoid…
Maintaining an Effective Safety Program - No Matter the Cost

Maintaining an Effective Safety Program - No Matter the Cost

Location: , United States
Category: Health and Medicine
Start Date: 01-27-2011
You’ve already had to make budget cuts during these challenging times and depending upon when the turnaround occurs there may be more in the future. What are you doing to illustrate the cost-benefit relationship your safety program has on your company’s bottom line? With proactive programs in place, strong safety programs protect your workers, your company assets and contribute to overall profitability of your company. During this webinar we will show how to make an effective case for your safety program by teaching how to conduct internal safety audits, showing senior management costs of injuries/OSHA penalties, ways to combat the…
Trial Master File for Research Sites: Can You Pass FDA Inspection?

Trial Master File for Research Sites: Can You Pass FDA Inspection?

Location: , United States
Category: Health and Medicine
Start Date: 01-27-2011
This course reviews the investigator TMF required and additional content for a clinical trial - the activities of set-up, maintenance, and quality control and assurance will be discussed, as well as common deficiencies and challenges. In this webinar, you will get guidance on the TMF. Learn the steps to take throughout a trial to ensure your TMF will pass inspection by FDA investigators and QA auditors. Areas Covered in the Seminar: Documents that should, and should not, make up a Trial Master File. Maintenance and quality control of the TMF. Start smart—the steps to take from Day One to create…
The World Congress 6th Annual Employer Health, Human Capital and Wellness Congress

The World Congress 6th Annual Employer Health, Human Capital and Wellness Congress

Location: , United States
Category: Health and Medicine
Start Date: 02-01-2011 Last Day: 02-03-2011
The 6th Annual Employer Health, Human Capital & Wellness Congress convenes 400+ CEOs and senior level financial, HR, and benefits executives from major Fortune 1,000 employers to share successful initiatives and real solutions for reducing the burden of healthcare costs. The goal is for delegates to leave with an action plan to capitalize on the measurable business value of healthcare benefits and innovation in wellness and prevention to increase employee engagement and performance. This year is especially critical as employers prepare for the transformation of the healthcare delivery system. Register By February 1 and save $200 when you call World…
Teens Using Drugs: What To Know and What To Do

Teens Using Drugs: What To Know and What To Do

Location: , United States
Category: Health and Medicine
Start Date: 02-01-2011 Last Day: 02-01-2011
"Teens Using Drugs: What To Know and What To Do" is a FREE, ongoing, two-part workshop series designed to help participants learn to understand, identify and address adolescent alcohol/other drug problems. Part 1 is presented on the first Tuesday of each month from October through June, provides information on how to understand and recognize the signs of a teen substance abuse problem, and includes a short video. Part 2 is presented on the second Tuesday of each month from October through June, provides information on what should and should not be done when a teen substance abuse problem is recognized,…
New Changes to HIPAA: The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel

New Changes to HIPAA: The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-01-2011 Last Day: 02-01-2011
Overview: New regulations modifying the HIPAA Privacy and Security Regulations have been proposed and/or finalized to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. New requirements for business associates of HIPAA covered entities and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restricting and accounting of disclosures and increased enforcement activity. All kinds of covered entities, and now, business associates of covered entities and their subcontractors as well, need to review…
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-01-2011 Last Day: 02-01-2011
Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you…
Payment Changes in Health Care are coming – Are You Prepared - HealthCare Webinar By ComplianceOnline

Payment Changes in Health Care are coming – Are You Prepared - HealthCare Webinar By ComplianceOnline

Location: , United States
Category: Health and Medicine
Start Date: 02-02-2011
This Healthcare Payment based webinar will discuss the payment changes and ways to prepare for the changes which are either implemented or going to be tested under healthcare reforms. Why Should You Attend: Healthcare providers will see significant changes as to how they are paid once the Patient Protection and Affordable Care Act is fully implemented. These changes will require changes to the relationship among them, particularly between hospitals and physicians. It is crucial that providers begin now to get ready for these changes so that they can maximize their success under the new payment and delivery models. Attend this…
Reprocessing REUSABLE Medical Devices-Cleaning & Labeling Requirements - Webinar By GlobalCompliancePanel

Reprocessing REUSABLE Medical Devices-Cleaning & Labeling Requirements - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-02-2011 Last Day: 02-02-2011
Overview: Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices. Why should you attend: Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if…
How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel

How to Prepare and Submit a Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-03-2011 Last Day: 02-03-2011
Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly…
Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-03-2011 Last Day: 02-03-2011
Overview: The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design, implement, and maintain a combination system that surpasses compliance requirements. The seminar will focus primarily on the principles embodied in CFR Parts 210-211 and ICH Q7A for…
Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel

Location: , United States
Category: Health and Medicine
Start Date: 02-03-2011 Last Day: 02-03-2011
Overview: Most sophisticated businesses use social media sites such as Facebook, MySpace, Twitter, and LinkedIn to promote their services, connect with their customers, and as a overall component of their business strategy. Physicians and other healthcare providers have begun to experiment in the social media environment, but most are concerned that the special rules applicable to the healthcare industry prevent or restrict their activities. In fact, the healthcare industry is subject to particularly restrictive rules that impact the manner and method with which they can use social media tools, particularly related to HIPAA and other medical privacy concerns. However, it…

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