Discuss Web-based Seminars

Accelerated PMP E Learning Introduction: This training program is conducted to expose the participants to an integrated approach to Project Management. It is designed to develop the necessary knowledge needed to manage projects effectively. Key Features: Live Online sessions, 7 lectures of 3 hrs each only on weekends, to continue for 4 weeks. Opportunity to discuss directly with the faculty & clarify all  more...

PAPERLESS HR - LEGAL PITFALLS TO AVOID WHEN YOU DECIDE TO GO PAPERLESS Many companies are considering or moving towards having a paperless a HR Departmenta . This informative audio conference presented by our legal expert, Melissa Fleischer, Esq. will discuss and clarify what this means for your company. Ms. Fleischer will also provide an overview of some of the legal challenges that companies face when deciding whether to go paperless and how to avoid these legal  more...

Time Management Training ... set priorities, develop an overall time management plan, discuss the Pareto principle, assign a price to time, conduct a time audit, and correctly identify and control poor time management personality types. Course activities also cover managing their time to increase their productivity, developing a daily plan, managing technology, and saying " no " to doing too much. Students will also  more...

Managerial Leadership Training ...als that are aligned with an organization ' s vision, and discuss the importance of planning changes before implementing them. Course activities also cover preparing employees for organizational changes, motivating employees through change, solving problems encountered during change, and helping employees deal with grief and stress during changes. Students will also learn how leaders can help  more...

Advanced Inter-Personal Communication Training This Advanced Inter-Personal Communication training course teaches students about interpersonal communication styles and techniques. Students learn how to ask and answer questions, use nonverbal communication, give feedback, and empower employees. Students also learn how to communicate with individuals who hold different positions in an organization, such as peers, supervisors, subordinates, and  more...

Presentations: Preparing, Developing, and Delivering ...he fundamentals of creating a presentation. Students will discuss the components of a good speech or presentation, and then they will learn how to develop their own. As students work through the activities, they will write and deliver three short presentations in class. They will be introduced to a variety of delivery techniques that include building rapport with the audience, using body  more...

Motivation Training ...discuss the foundations of motivation. They will examine motivating and demotivating factors as well as negative thoughts. They will also discuss motivation theories and the benefits of motivation. Students will examine the concept of having a Positive Mental Attitude, and how they can work towards a PMA in their lives. During this course, students examine in detail the fundamentals of the core  more...

The Most Important Metrics For Measuring Supply Chain Performance ...ought to us by the Six-Sigma world, will be presented and discussed in this live and interactive 90-minute webinar. The a Modem Chat Seriesa Webinar leader will explain each of these common metrics and demonstrate how each is calculated. Participants will be encouraged to share their ideas and views in this fully interactive LIVE web conference format. Participants should be prepared to  more...

Better Methods for Maintaining Accurate Operation Standards ...erence format. Participants should be prepared to openly discuss their ideas and to interactively comment on other participanta ™s ideas presented during this LIVE webinar. This program should be attended by anyone who is responsible for, or depends upon, accurate operation standards. The program should be particularly beneficial to anyone who is benchmarking other organizations'  more...

Early Intervention Field Trauma Training First responders (e. g., fire/ rescue, emergency medical services, law enforcement) as well as mental health and health care professionals will benefit from Field Trauma training. This is an entry-level program and no pre-requisites are required to receive the Field Trauma designation other than successful course completion. Participants will learn about on-site responding and learn how to respond  more...

How to Calculate the Impact on Total Factory Costs from a One Percent Change in Planned Load ...oad means to profitability and enterprise value. We will discuss: a How to calculate the impact on profits derived from a 1% change in annual planned load. a What costs are included in variable, semi-fixed and fixed cost categories overcoming myths of accounting for variable costs. a How to differentiate escapable from non-escapable costs the role variable  more...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 - GlobalCompliancePanel Overview: This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.  more...

FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media - Webinar By GlobalCompliancePanel ...discuss the FDA's current thinking on good practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e.  more...

Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco Overview: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide  more...

FDA Compliance for Drug and Medical Device Labeling and Off Label Promotion What is Acceptable or Not Acceptable - Webinar By Gl Overview: This webinar is intended to discuss the best practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). Wednesday, March 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar By GlobalCompliancePanel This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Tuesday,  more...

FDAs Revised Draft Guidance on Medical Device Changes and the 510k - Webinar By GlobalCompliancePanel This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. Wednesday, January 25, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC ...ebinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDAa ™s draft  more...

HIPAA Breach Notification How to Prevent Prepare for and Report Breaches of Healthcare Information Privacy and Security - Webina We will discuss the kinds of threats that exist for PHI and how they're changing as the hackers gain experience and abilities, and why you need to prepare for next-generation attacks now. Wednesday, December 7, 2011 10: 00 AM PST | 01: 00 PM EST  more...

HIPAA Security Rule Compliance When Communicating with Patients Using Mobile Devices - Webinar By mentorhealth The session will discuss the requirements, the risks, and the issues of the increasing use of mobile devices for patient communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction. Tuesday, November 29, 2011 10: 00 AM PST | 01: 00 PM EST  more...

The Investigational Device Exemption When is it Needed and How is it Obtained Most Easily - Webinar By GlobalCompliancePanel ...discuss the situation of the "sponsor/ investigator," where a person doing research is sponsoring the research as well. This might be a physician who has designed a new instrument to be used in his practice, or an inventor doing a preliminary evaluation of his invention using human subjects. The situation in which a physician uses a legally-marketed device for a purpose other than that which it  more...

The 510k Process Risk Management - By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

The 510k Process Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

The 510k Process and Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products.  more...

Calibration Concepts for Auditors and Reviewers - Webinar By GlobalCompliancePanel This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option.  more...

Practical Laboratory Statistics ...atory data, you will want to attend this seminar. We will discuss the basics in a way that doesn't involve lots of jargon and complicated equations. We use real world examples and common spreadsheet functions to show you how to analyze your data. Areas Covered in the Seminar: Perspectives on statistics Basic definitions Hypothesis testing Evaluating differences in precision - the F Test  more...

HIPAA and Security Breaches Most frequent issues and causes and trends for future threats by GCP The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations  more...

Preventing Harassment in the Workplace by TrainHR This webinar will concentrate on what is considered sexual harassment as well as covering other types of harassment in the workplace. It will review the laws protecting employees from harassment and the recourses employees have. It will define who is covered and describe the two main kinds of sexual harassment in the workplace. It will cover what should be in an effective Harassment policy, how  more...

HR Metrics for the Human Resource Executive by TrainHR ...discuss measurements and ratios that will be meaningful to the Human Resources Department and the Executive Team in determining successful use of human capital. Human Resources uses both left and right brain thinking to achieve its objectives and key metrics for both will be covered. We will also give you practical ongoing measurement tools that should apply to all types of organizations and  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates. We will explain the enforcement regulations and their recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10, 000. We will discuss what information and documentation needs to be prepared in  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ... ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory personnel need to be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. According to the FDA, if it isn't written down, it didn't happen. As well, if it isn't written down clearly, it didn't happen either. GMP  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ... other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as provide up-to-date information on any expected changes. Attendees will learn what information is covered under the HIPAA and PCI rules and what are the ways the information should be protected, including the safeguards called for by HIPAA and PCI. They  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...logy. A SaaS CRM system will be utilized as an example to discuss what drives SaaS system compliance and how requirements can be limited to Customer specific configurations. The scope of the validation effort will be explained and the elements of the Validation effort will be outlined. Change Management will also be discussed, with regards to how Vendor changes and customer configurations  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...ample size to making the accept/ reject decision. We will discuss the following issues: * How to use the sampling tables to determine the sampling plan * Ways to avoid common errors and misunderstandings with the sampling tables * The difference between single, double, and multiple sampling plans * Why double sampling plans are the most economical choice * The reasons  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...y what garment systems are available. * Identify and discuss good and bad cleanroom gowning. * Identify gowning techniques and sequence. * Discuss what role each garment part plays in contamination control and human safety. * Explore expectations of cleanroom garment suppliers. * Discuss cleanroom gowning tests and personnel qualification. Who Will Benefit: *  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...ve webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of cleanroom cleaning  more...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...discuss the evolution of the standards, describe a Pharmaceutical Quality System and discuss the transition to the Pharmaceutical Quality System. Why you should attend: The US FDA, and regulatory agencies around the world, are actively promoting the concept of a Pharmaceutical Quality System. The concept of a Quality System was imposed on the medical device industry through the  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...reach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations. * HIPAA Covered Entities and Business Associates need to know where and what information they have, so they can know if there has been a breach, and figure out how serious a breach may be and whom to notify  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ... review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements. Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product, important characteristics of  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...o over the challenges that subject recruitment brings and discuss the strategies that you should consider. You will also learn the reasons subjects do and do not participate in clinical trials and why the recruitment phase of a clinical trial is so important. The importance of a good "Recruiting and Community Relations" department eliminates failure as a option. Why should you attend:  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ...ind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and weaknesses of each approach. If you must generate and evaluate calibration  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III. Areas Covered In the Seminar: * Create and use a recall operational procedure and what should it contain *  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ... Review literature and other available information * Discuss the therapeutic areas with experts in the company and externally such as key opinion leaders, patient groups may also be of help * Decide on the study design potential locations for the study (eg which countries have a high incidence of the disease, where do you propose to market the drug * Identify potential locations  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...tually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its selection, audit, use and on-going relations with its suppliers of services and products / components. How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...ng. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...tually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems. Change can be beneficial, but is often the cause of new and even worse problems than those the change was designed to eliminate. It can be the root cause of a major problem, cGMP "entropy". Proper change control is  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...phasis based on this new regulatory climate. We will also discuss proven methods to prove to the FDA that known company cGMP deficiencies should not be a major concern to the Agency, and which may 'eliminate' the possibility of a deserved Warning Letter. Why you should attend: The FDA says it's getting tougher. Recent audits and other enforcement actions indicate that's true. The past ways  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...ercise "regulatory discretion" and what that means. We discuss the following issues: * The pitfalls of using Excel without a good regulatory plan * How to recognize when you are using software in production or the quality system * The use of Excel tools to help ensure spreadsheets are built correctly * The FDAa ™s requirements and expectation for production and  more...

Practical Laboratory Statistics - Webinar by GlobalCompliancePanel ...atory data, you will want to attend this seminar. We will discuss the basics in a way that doesn't involve lots of jargon and complicated equations. We use real world examples and common spreadsheet functions to show you how to analyze your data. Areas Covered in the Seminar: * Perspectives on statistics * Basic definitions * Hypothesis testing * Evaluating differences  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...the pharmacist. Areas Covered in the Session: * Discuss the types of federal criminal and civil actions that can be imposed on a pharmacy pertaining to the purchase, sale, transfer, dispensing, destruction and theft or loss of Schedules II through V controlled substances. * Identify the responsibilities of DEA through their Diversion personnel to enforce federal laws and DEA  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...reign trial data as pivotal data for NDA approval; * Discuss how FDA is implementing these rules and what you can do to assure compliance; and * Recognize design considerations and requirements for foreign trials Who will benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ... Boards (IRBs). Areas Covered In the Seminar: * Discuss how QA differs from QC and who is responsible for each * Determine who gets audited and factors and metrics for assessing when or why to audit * Discuss guidelines on how the FDA trains its investigators to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs) * Review recent  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...r participation in the course. The presenter will also discuss his many experiences designing and implementing quality systems. Why Should You Attend: Many quality professionals fear the FDA because they perceive the regulations to be very structured and at the same time open for interpretation. They further perceive the FDA as being the experts interpreting the regulations. It is true  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ... health information for healthcare professionals. We will discuss how disclosures must be tracked. Why you should attend: The HIPAA Privacy and Security Regulations have been modified by language in the HITECH Act within the American Recovery and Reinvestment Act of 2009 and the resulting changes in the regulations issued as interim final rules (IFRs) and notices of proposed rule making  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...ensed products. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ...ern to the regulators. In this webinar we will review and discuss FDA 483 laboratory operation based observations, analyze the cause and propose measures to prevent similar observation on other laboratories. Areas Covered in the Session: * Regulations * Inspectional Guidances * Laboratory controls * Specification, standards, sampling plans, test procedures *  more...

Complaint Handling in Compliance with FDA and ISO Regulations - Webinar by GlobalCompliancePanel This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also  more...

GMP Expectations for Products Used in Early Phase IND Studies - Webinar by GlobalCompliancePanel FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the  more...

The ICF Process Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel The ICF process, which involves communication between a consentee (patient/ subject) and a consenter (staff clinician/ designee), is a vital component to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear  more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol.  more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel 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  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective  more...

Best Practices in Complaint Management - Compliance Webinar by GlobalCompliancePanel Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements  more...

Failure Modes and Effects Analysis FMEA - An Effective Tool for Medical Device Risk Management - Compliance Webinar by GlobalCom The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.  more...

Tax Lien Investing Webinar- Series I Gain a clear understanding of the advantages and risks associated with real estate tax liens and/ or real estate tax deeds with expert help from Howard Liggett during this 90-minute online Webinar training presentation. He will discuss the ins-and outs of tax sale investing, including key differences between tax liens and tax deeds.  more...