Est Web-based Seminars

HR BOOT CAMP FOR MANAGERS Managers often get promoted to be a manager with no formal training on how to manage to ensure legal compliance. This nut and bolts how-to on-line HR Bootcamp webinar will provide your managers will everything they need to know to prevent liability in your workplace. Train your managers with HR Bootcamp on the employment discrimination laws including Title VII, ADA, ADEA, FMLA and how to  more...

TOP 10 TIPS FOR CREATING A BLOGGING AND SOCIAL MEDIA POLICY Social Media is changing the face of the workplace in America. The explosion of this new method of communication including Twitter, Facebook, My Space, Linkedin and Blogs has raised new legal challenges for employers. These challenges require that HR become even more diligent in developing policies and procedures to avoid liability and protect the employer. Join us for this informative and  more...

Conducting Discrimination Investigations Webinar ...ESTIGATIONS What do you do once you receive a discrimination or harassment complaint? Learn how to conduct a legally compliant thorough investigation including tips for successful interviews of witnesses. Gain practical skills that enable you to conduct effective investigations of discrimination, harassment and retaliation complaints. Sign up Now! Date: June 26, 2012 Time: 1: 00-2:  more...

LABOR RELATIONS TRAINING ...hem by the union contract. All this and more in this interesting a how toa course on effectively managing all of your employees in a represented environment. This course can be customized to include your actual collective bargaining agreement and an explanation of the important provisions in such agreement. If you would like us to customize this seminar to include your collective bargaining  more...

SUBSTANCE ABUSE AND THE ADA WHAT YOUR MANAGERS NEED TO KNOW ...Find out how each of these is treated by the ADA and get best tips on how your managers can best manage these employees and still be legally compliant. In this 60 minute webinar presented by attorney Melissa Fleischer, you will learn: a Tips to keep in mind when handling workplace substance abuse issues a Misconceptions that may lead to discrimination against employeea ™s with  more...

From Hiring To Firing What Every Manager Needs to Know FMLA, ADA, ADEA, GINA and USERRA. Learn how to avoid liability under each of these statutes. Find out how each of these laws interacts with the others to ensure that your company is in full compliance and adequately protected. Most employers do not know that in many states the state employment discrimination laws apply to employers with small numbers of employees such as 4 or more employees. In  more...

Top Tips To Prevent Workplace Violence in your Workplace ... violence. Date: July 5, 2012 Time: 1: 00-2: 00 p. m. EST Cost: $199 per attendee per computer terminal Registration: Register On-Line Now. Add to your shopping cart. You may also contact us at 917-417-1715 or via e-mail at info@hrlearningcenter. com. About Your Speaker Ms. Fleischer is the Founder and President of HR Learning Center LLC, a human resources consulting firm  more...

Employee Handbooks Dos and Donts ...st contain Date: July 3, 2012 Time: 1: 00-2: 00p. m. EST Cost: $199 per attendee per computer terminal Registration: Purchase on-line now at hrlearningcenter. com/ employeehandbooksdosanddonts-2. aspx. For more information, contact us at info@hrlearningcenter. com. About Your Speaker Ms. Fleischer is the Founder and President of HR Learning Center LLC, a human resources  more...

Top Tips For Managers to Prevent Harassment in your Workplace ...est protection is for managers to understand what their responsibilities are and learn tips to help them prevent harassment in the workplace. This interactive, informative sexual harassment prevention training, "Top 10 Tips for Preventing Harassment in Your Workplace," will provide the tips that managers should not be without. It includes a definition of sexual harassment and discussions of  more...

Risk Assessment - Compliance Using Easy To Fill Out Documentation - Webinar By GlobalCompliancePanel Overview: This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. Wednesday, June 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar GlobalCompliancePanel Overview: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. Tuesday, May 8, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Post-Design Medical Device Risk Management - Webinar GlobalCompliancePanel Overview: In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. Tuesday, April 24, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Use of Risk Management during Process and Design Validation - Webinar GlobalCompliancePanel Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. Tuesday, April 3, 2012 10: 00 AM PST | 01: 00 PM EST  more...

IEC62304 - Development and Maintenance of Critical Software - Webinar By GlobalCompliancePanel Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Wednesday, March 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Proper Documentation of Risk Management for Compliance with ISO 14971 - Webinar By GlobalCompliancePanel There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. Tuesday, May 8, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Post-Design Medical Device Risk Management - Webinar By GlobalCompliancePanel In this presentation we will explore the requirements for post-design risk management and determine how to apply the requirements. Tuesday, April 24, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Use of Risk Management during Process and Design Validation - Webinar By GlobalCompliancePanel Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. Tuesday, April 3, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Understanding Analytical Test Results Comparing Two Sets of Data - Webinar GlobalCompliancePanel ...ss will cover the understanding the properties of single test results and how they may be compared. There are many problems that arise from a misunderstanding of the properties of single data sets and the problems are compounded when data sets are compared. The discussion will cover the misconceptions and present methods to allow proper comparisons, while considering the risks inherent in  more...

Interfacing Design Verification Process Validation and Design Validation - Webinar GlobalCompliancePanel Overview: There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements. Tuesday, March 13, 2012  more...

Writing and Maintaining Quality Standard Operating Procedures SOPs to Guarantee FDA Compliance - Webinar By GlobalCompliancePane A cogent understanding and thorough knowledge of the regulations for SOPs is a necessity for product development and clinical testing organizations with the goal of agency approval, and product commercialization. Thursday, March 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Conducting Successful Product Complaint Investigation - Webinar GlobalCompliancePanel 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. Thursday, March 22, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Webinar By GlobalCompliancePanel This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which  more...

Essentials of Drug Safety and Pharmacovigilance - Webinar By GlobalCompliancePanel This webinar is designed to give pharmaceutical and biologic companies operating in the U. S. and EU an introduction to the fundamentals of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities. Thursday, April 19,  more...

Preparation for FDA EU Pharmacovigilance Inspections - Webinar By GlobalCompliancePanel This webinar is designed to give pharmaceutical firms operating in the US and EU practical information, practices and insight to help ensure compliance with the most recent drug safety and pharmacovigilance regulations. Tuesday, April 3, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Title 21 Code of Federal Regulations for Food and Drugs - Webinar By GlobalCompliancePanel Overview: United States Food and Drug Administration ("FDA") is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe. Thursday, March 29, 2012 10: 00 AM PST | 01: 00 PM EST  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...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements - Webinar By GlobalCompliancePanel Any medical device that is legally in the U. S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Thursday, March 8, 2012 10: 00 AM PST | 01: 00 PM EST  more...

South Korea Navigating the Clinical Trial and Regulatory Environment - Webinar By GlobalCompliancePanel This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceutical Products in South Korea. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in South Korea. Tuesday, March 27, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Business Process Optimization in Pharmacovigilance - Webinar By GlobalCompliancePanel Overview: This webinar will describe how to assess and optimize Pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the  more...

How to Develop Monitor and Effectively Communicate your Risk Control Strategy - Webinar By GlobalCompliancePanel Overview: The intermediate level webinar assumes that attendees are conversant with the basic concepts of QRM. It addresses how to document the results of QRM in a RCS document, techniques to continuously monitor RCS performance and reporting of risk events and remediation to stakeholders. Subsequently, the focus shifts to the development of a process framework to manage risk through activities  more...

Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates  more...

Post Market Surveillance for Medical Devices - Webinar By GlobalCompliancePanel Post market surveillance is changing, not only in the US, but also in the EU and Canada. Thursday, March 22, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated - Webinar By GlobalCompli This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. The FiM and other Phase I studies set the tone of all future Pre NDA studies. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans - Webinar GlobalCompliancePanel Overview: This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Thursday, March 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Verification vs Validation in Regulated Industries - Webinar By GlobalCompliancePanel Overview: Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles. Thursday, March 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Thursday, February 16, 2012 10: 00 AM PST | 01: 00 PM EST  more...

The 510k Submission Requirements Contents and Options - Webinar GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine 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). Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Safety Critical Software - Software Risk Management - Webinar By GlobalCompliancePanel Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Tuesday, February 7, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Drug Development Process - From Discovery to Marketing - Webinar By GlobalCompliancePanel This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. Wednesday, February 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, February 2, 2012 10: 00 AM PST | 01: 00 PM EST  more...

FDAs 21 CFR 11 Add-On Inspections - Recent Updates - Webinar By GlobalCompliancePanel This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Tuesday, February 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Key Factors to Write an Effective Standard Operating Procedure SOP Work Instructions WIs - Webinar By GlobalCompliancePanel This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Tuesday, February 7, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing  more...

Residual Moisture Testing - Proven Techniques - Webinar By GlobalCompliancePanel This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Wednesday, February 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Lyophilization Process Development and Cycle Design with a Case Study - Webinar By GlobalCompliancePanel This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. Wednesday, January 11, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Computer System Validation Step-by-Step - Webinar GlobalCompliancePanel This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. Thursday, January 26, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Verification of Compendial Methods according to the New USP Chapter 1226 - Webinar By GlobalCompliancePanel This webinar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Supply Chain Integrity and Security - Webinar By GlobalCompliancePanel The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for sustainable, root cause solutions, we must also turn our  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Risk Assessment - Compliance Using Easy To Fill Out Documentation - Webinar By GlobalCompliancePanel This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. Tuesday, February 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Efficient Computer System Validation - 10 Easy Steps - GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Wednesday, February 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation to Eliminate 483s - GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, March 20, 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...

Key Steps for Risk Assessment - Webinar By GlobalCompliancePanel The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as  more...

Risk Analysis for Portfolio of Drug Development Programs - Webinar By GlobalCompliancePanel Building in strategic risk scenarios into portfolio planning can buffer the organization against the unexpected. Examples might be clinical trial failure, shifts in the marketplace or insufficient resource capacity. This webinar covers various portfolio planning tools and techniques with a focus on strategic risk management. Thursday, February 2, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Portfolio Optimization for Global Drug Development - Webinar By GlobalCompliancePanel ... The goal is to meet strategic objectives selecting the "best" portfolio of internal and external drug development programs for funding and balance company resources including money, manpower and manufacturing capacity. Projects could be interdependent, have multiple development scenarios, and are subject to multiple business rules specific for the company environment. Value of each project  more...

Master Verification Validation Planning under US FDA CGMP ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCom FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. Wednesday, March 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

DHF DMR DHR and the Technical File-Design Dossier - Similarities and Differences - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Wednesday, March 7, 2012 10: 00 AM PST | 01: 00 PM EST  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...

US FDAs Strategic Priorities for 2012 and Beyond - Webinar By GlobalCompliancePanel This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2012. Wednesday, January 11, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Statistics in Quality Control - Critical decisions-Risks Basics - Webinar By GlobalCompliancePanel Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Change Control Management From Design to Commercialization - Webinar By GlobalCompliancePanel There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/ systems specifications in addition to the more formal change control after the qualification of these systems. Thursday, January 12, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Changes in the EU Medical Device Directives 2010 Modifications and the 2012 Recast of the MDD Directives -Changes in the EU Medi This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectation - Webinar By G This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar GlobalCompliancePanel In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Dental Digital Radiography - Better for the Patient and the Practice - Webinar By mentorhealth This webinar is for those wondering what digital radiography is, how it differs from film, how it works, and how it impacts the dental office. And for those unsure which system to purchase and how to incorporate it into Their practice? It is also for those who are using it and learn how to use it more effectively. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...

How to Survive a DEA Inspection Series For a Research Facility - Webinar By mentorhealth The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Why is Drug Induced Liver Injury an Important Mirror of Drug Safety and How to Spot this early - Webinar By mentorhealth Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1: 10, 000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. Wednesday, November 30, 2011 10: 00 AM PST | 01:  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...

What is New in Ultrasonics Exploring Piezoelectric Technology - Webinar By mentorhealth Ever wonder what "the Piezo" is all about? What makes it so different from "the Cavitron"? This course is designed to examine the unique capabilities of piezoelectric ultrasonics and the role micro-ultrasonics play in contemporary periodontal therapeutics. Discussion of hand scaling versus power scaling will be explored, as well as an overview of the various piezoelectric ultrasonic devices  more...

Risk Management in the Pharmaceutical Supply Chain - Webinar By GlobalCompliancePanel Supply chains for pharmaceutical products have become increasing complex as the industry has outsourced many non-core activities to third party contractors and sought lower prices for their materials around the global. Tuesday, December 13, 2011 10: 00 AM PST | 01: 00 PM EST  more...

New Process Validation Life-Cycle Approach - Apply statistical tools to demonstrate Process Capability - Webinar By GlobalCompli This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Hazard Analysis A practical guide - Webinar GlobalCompliancePanel Hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time. Tuesday, December 6, 2011 10: 00 AM  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Wednesday, December 14, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviation - Webinar By GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, December 8, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Leadership - In the Non-Leadership Position - Webinar By GlobalCompliancePanel This webinar will provide valuable guidance to personnel in regulated companies who are in roles viewed as merely support to those in formal leadership positions. Wednesday, December 7, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Master Production Record Requirement - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. Tuesday, December 20, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Analyzing and Reporting Financial Outcomes in the Hospital Industry - Webinar By mentorhealth This 90 minute webinar has been designed to dispel the myth that information is not available in the healthcare industry to good and rational financial decisions. Tuesday, November 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth Hospital executives have a hard job to do! In attempting to create and achieve an effective strategic plan, there is a great need to determine specific outcomes that will be consistent with the organization's underlying mission, broad policies, culture and accepted industry normsa .But what exactly does this mean? What are the elements that will be instantly recognizable as "a" or "the" key  more...

Responding to FDA 483s - Webinar By GlobalCompliancePanel Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. Wednesday, November 30, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Troubleshooting Ethylene Oxide EO Processes - Webinar By GlobalCompliancePanel Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Important Sterilization Information for Product Developers - Webinars GlobalCompliancePanel Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes and its impact to the functionality of the product and its package. Tuesday, November 29, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Conducting Successful Product Complaint Investigations - Webinar GlobalCompliancePanel This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Bullet Proof 510k - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel 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. Thursday, November 17, 2011 10: 00 AM PST | 01: 00 PM EST  more...

New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel This presentation will help you to understand the last changes that occurred in Canadian ethics regulations. The presentation will clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the  more...

Design History File DHF the Device Master Record DMR and the Device History Record DHR Principles on Lean Documents and Lean Co Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Tuesday, December 13, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration - Webinar By GlobalComp Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Tuesday, November 22, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar GlobalCompliancePanel This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. Tuesday, November 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation to Eliminate 483s - Webinar GlobalCompliancePanel This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, December 6, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Dental Digital Radiography - Better for the Patient and the Practice - Webinar By mentorhealth This webinar is for those wondering what digital radiography is, how it differs from film, how it works, and how it impacts the dental office. And for those unsure which system to purchase and how to incorporate it into Their practice? It is also for those who are using it and learn how to use it more effectively. Wednesday, April 11, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Medical Coding for Dental Sleep Apnea Treatment - Webinar By mentorhealth This webinar will provide the information that dental practices need to be able to truly help their patients afford this life saving treatment. All areas of helping dental practices implement this profit boosting system will be discussed. Thursday, April 26, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Best Practices in Key Financial Metrics - Webinar By mentorhealth Hospital executives have a hard job to do! In attempting to create and achieve an effective strategic plan, there is a great need to determine specific outcomes that will be consistent with the organization's underlying mission, broad policies, culture and accepted industry normsa .But what exactly does this mean? What are the elements that will be instantly recognizable as "a" or "the" key  more...

Treatment Planning Non-Surgical Periodontal Therapy Cases - Webinar By mentorhealth This one hour interactive webinar introduces both dentists and hygienists into the world of non-surgical periodontal therapy. Tuesday, April 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

PMP Certification Virtual Training Course Preview ...lass Days: Tuesdays and Fridays Class Times: 7PM to 9PM (EST) Class 2 Start Date: Monday March 7, 2011a Thursday April 21, 2011 Class Days: Mondays and Thursdays Class Times: 9: 30AM to 11: 30AM (EST) Class 3 Start Date: Monday March 7, 2011a Thursday April 21, 2011 Class Days: Mondays and Thursdays Class Times: 130PM to 330PM (EST) Class 4 (Weekends) Start Date: Saturday  more...