Must Web-based Seminars

Grow Spiritually Succeed Managerially Thinking is an art, a skill and one needs to practice it like a musical instrument or a sport. A successful manager or a leader must learn how to use this wondrous equipment in order to think, to reason and decide his / her course of action(s) in personal as well as professional life. Learning Objectives: History of human development, Intellect Vs Intelligence, Objectivity at work, 3 C's of  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 ...that attorneys often use and emphasizes that the employer must have a zero tolerance towards workplace violence of any kind. HR Learning Center's workplace violence training webinar provides a thorough understanding and review of what the employer's workplace violence prevention policy should include and instructs employees on the proper methods to file a complaint of workplace violence.  more...

Employee Handbooks Dos and Donts ... make that reek havoc for employers. Learn what policies must be in your employee handbook as well as phrases and terms that you should never use in such a handbook. This informative seminar will outline for you the dos and dona ™ts of drafting an effective well-written employee handbook. It will examine what the courts have said on these issues and provide practical tips on avoiding  more...

AVOID LEGAL PITFALLS OF DRAFTING JOB DESCRIPTIONS Job Descriptions are legal documents that can and often are used in a court of law as evidence against an employer. Learn how to avoid the legal pitfalls of drafting these legal documents and best practices for drafting all of your job descriptions. This on-line live webinar will help you avoid legal problems related to the Americans with Disabilities Act, employment discrimination and  more...

Tips To Avoid Liability When Terminating Employees ...must for all employers. Learn how to protect your company and yourself in this workplace law guide to terminating employees that provides some top tips for avoiding liability. Nothing causes more problems for employers than terminating an employee. Attend this informative one-hour seminar to learn how to avoid the top mistakes that employers often make when terminating employees. Understand  more...

Introduction to Visual Basic 2008 Training ...earn all the Visual Basic 2008 language features that you must internalize in order to create full-featured Web or Windows applications that make best use of the .NET 3.5 platform.You will learn about data types, variables, and operators, along with all the important flow control structures. You ' ll work through several examples demonstrating the power of the .NET 3.5 Framework, and dig into  more...

Oracle Database 10g: Administration Level II ...that of recovery from failure, especially if the recovery must not result in a loss of any data. This Oracle trainig class presents all the standard failure scenarios and the best recovery strategies for each. Strategies for on-line backups, complete and incomplete recovery, media recovery vs. flashback database recovery and many other subjects are discussed. Extensive  more...

Introduction to C# 2008 Training ... there, you will learn all the language features that you must internalize in order to create full-featured Web or Windows applications that make best use of the .NET platform.You will learn about data types, variables, and operators, along with all the important flow control structures. You will work through several examples demonstrating the power of the .NET Framework 3.5, and dig into  more...

MOC 5117 - Installing, Configuring, Troubleshooting, and Maintaining Windows Vista This Windows Vista training class provides IT Professionals who work in enterprise organizations with the knowledge and skills to install, deploy, configure, secure, maintain, and troubleshoot Windows Vista. This advanced course is aimed at enterprise desktop support technicians who want to gain an in-depth knowledge of Windows Vista.This class targets experienced IT professionals who focus on a  more...

Measuring Performance of Your Global Procurement Organization How to Shape Behaviours in Global Purchasing ...at is really important. - Components of Total Cost that must be addressed to properly compare supply alternatives. - Inputs necessary to properly calculate a cost reduction curve that can be used to predict total material costs. - Methods for determining how a 1% reduction in purchase-spend translates into changes in enhanced profits, reduced gross assets and improved enterprise  more...

How to Dramatically Improve the Quality of Your Shipment ForecastsTechniques to Improve Forecast Inputs ...must NEVER stop thinking about the integrity of the shipment forecast. This is because a shipment forecast represents independent demand for company product which in turn drives the Master Production Schedule (MPS) process. Start with an inaccurate shipment forecast and a poor performing MPS is sure to follow. Continue with a poor forecasting process and inventory will surely balloon at the  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...ic results and departmental performance. Today's manager must measure, monitor and report the condition of data utilized in the decision making process much the same way pollsters and scientists measure the quality of data going into their political polls and scientific experiments. Specifically, this important webinar focuses on the following THREE critical issues that can ultimately  more...

Supervision in Clinical Traumatology ...s, families, organizations and communities. *Participants must complete courses TI-1001 & TI-202 to TI-207 in order to enrol in this course. OBJECTIVES: Supervision in Clinical Traumatology offers a framework for participants to practice and demonstrate proficiency in clinical traumatology skills. The program is offered in a format designed to challenge and help participants grow into  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...

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...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...prepared to respond to audit requests. The features that must be available in EHR systems and the questions to ask system vendors will be described. The processes for responding to requests for copies of electronic records and accountings of disclosures will be related to the regulations that require them. The role of business associates who maintain or support your EHR will be discussed,  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...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel ... withdrawn. Devices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the requirements of the new standard. Areas Covered in the Session: ISO 14971 compliance is a requirement of IEC 60601-1 The new standard uses risk  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...

Calculating Overtime Correctly - Webinar By TrainHR ...s to inclusion of payments in the regular rate When you must include a bonus in calculating your employeea ™s overtime pay How to handle overtime calculations once you've determined that a bonus qualifies as includable wages How to calculate the overtime premium When and how to use the "fluctuating workweek" method Who Will Benefit: Payroll Professionals Human Resources  more...

Documentation Path to Home Health Compliance - Webinar By mentorhealth In the current environment of high deficits and economic instability, home health agencies must constantly be vigilant to ensure they are being good stewards of public dollars. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Excel Spreadsheets and FDA Device Regulations - Webinar By GlobalCompliancePanel This seminar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc The different types of internal audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are  more...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

How to Survive a DEA Inspection Series For Analytical Labs and Researchers - Webinar By GlobalCompliancePanel 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.  more...

How to Survive a DEA Inspection Series Only Manufacturers and Distributors - Webinar By GlobalCompliancePanel This training will cover DEA record-keeping and security requirements that a registrant must comply with when handling controlled substances and regulated chemicals. It covers elements of what occurs during unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling those products, you will get a better understanding of what is  more...

Statistical Concepts of Process Validation BY GCP 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".  more...

How to Conduct an Offensive Behavior Investigation by TrainHR This program will help you understand how to conduct discrimination and harassment investigations. Learn how to avoid the legal pitfalls of conducting discrimination investigations. Learn how flawed investigations can cause nightmares for employers. Understand when you need to call in a professional to conduct your investigation. Receive updates on the most recent cases on these issues and  more...

The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - Webinar By Globa The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately.  more...

How to Survive a DEA Audit - Webinar By GlobalCompliancePanel this training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals.  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...ndwritten entries. Personnel, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this webinar, you will review agency and industry standard expectations of Good Documentation Practices plus see examples of these practices (both good and bad!) as they apply to the pharmaceutical  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...attend: Increasingly U. S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/ DD is moving in the  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...d portable data devices. All entities covered under HIPAA must take special care of electronic patient health information, including establishing policies and procedures to protect all kinds of PHI and taking regular actions as part of a security management process. Proposed changes and expansions to HIPAA, going into effect in 2011, dramatically expand the types of entities to which the  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...d in the Session: * Health and payment information must be kept securely - learn what is required and what is a good way to attain compliance with multiple regulations * HIPAA and PCI have many similarities, but some important differences as well. Keeping your information well controlled can help with both. * Find out about how you can discover where payment card information is  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ... * Find out what the rules are that health care providers must follow, why they are important, and what the penalties are for not complying, including the new penalties for willful neglect of compliance, which begin at $10, 000. * See how the risk analysis requirement for meeting the privacy and security objective of meaningful use, necessary for federal funding, fits in with HIPAA  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ... / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is clear. Covered also will be what the practices are that ensure subject safety and credible  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...and their patient. It is imperative that medical products must perform consistently so that patients can be treated in a predictable manner to treat, cure, and diagnose disease. Areas Covered in the Session: * Defining IQ/ OQ and validation and its role in maintaining product quality * Roles and responsibilities in the validation process * The process validation lifecycle  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...quirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always been part of the US FDA's GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as  more...

FMEA and Risk Management for Medical Devices - Webinar By GlobalCompliancePanel ...agement to Medical Devices, all facets of risk management must be considered from cradle to grave. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management". Areas Covered in the Session: * Failure Mode Analysis Terms * Risk Management and FDA * Risk Management in Design Control * Risk Management & ISO  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...ort, training and general use of the Test Management Tool must be considered, prior to deciding if a Test Management Tool should be used to maintain the companies corporate validation policies. This presentation will provide details regarding Implementation, Configuration, Operations, System Maintenance, Training and Testing Automation considerations. Why should you attend: This webinar  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...major source of contamination in cleanrooms, special care must be taken to choose and provide proper garments to minimize the human impact on cleanroom quality. Gowning systems are varied in material, composition, coverage, and control capabilities. The use and donning of the garments can also vary and needs to be controlled in order to establish a consistent manufacturing environment.  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ...ussions of missing or doubtful data, laboratory employees must follow good documentation practices. According to the FDA, if it isn't written down, it didn't happen. As well, if it isna ™t written down clearly, it didna ™t happen either. GMP compliance (21CFR, Part 211) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...nished product, and even in-house manufactured components must meet certain specifications and/ or regulatory requirements to ensure the identity, strength, quality and purity of the lot. The intent of this program is to define a process that helps to ensure that all lot dispositions are performed consistently and in compliance with sound quality management systems. Areas Covered in the  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ct, important characteristics of the Risk Management Plan must be documented to meet requirements. In situations where development and manufacturing activities are located in different areas and are under different management structures, the Risk Management Plan must document the divided responsibilities and activities. The plan must cover all phases of the product lifecycle risk management  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...t only is this information useful for CRO's, the sponsors must also know what is needed so they can chose the right CRO or research site to conduct their studies. Areas Covered in the Session: * How to set up and track your recruiting of subjects * The challenges of successful recruiting * The importance of your recruiting staff in the overall success of the unit or site  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ...uss the strengths and weaknesses of each approach. If you must generate and evaluate calibration "curves" we will show you why the correlation coefficient is only one option for the evaluation, and why sometimes it can give a false indication of the curve fit. Finally, we can illustrate these concepts by examining several real-world data sets from a variety of different analytical instruments.  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...ified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...nt quality. But what about supplier quality? Your company must have a procedure in place that describes the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered "approved." You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain "approved." You  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...e the required update periods * Clarification of who must provide establishmentsa ™ registration numbers Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms, importers and those who need to register their device firms and list their device(s). The employees who will benefit include: All levels of management and departmental  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...th. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly,  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...DA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually 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  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...er" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually 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  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results you want. We explain the built in Validation tools and how to use them to prevent the user from entering incorrect data. We explain the use of Formula Auditing to help ensure the calculations  more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel 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  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...ilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the U. S. and take a renewed look at "grandfathered" product by the Agency is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...ve and efficient tool that contributes to performance, it must be done properly. Areas Covered in the Session: * Review of GMP regulatory expectations of training (FDA and EU) * Recent training-related citations * High-Level description of a training system, including elements (needs analysis through evaluation), basic training documentation, management, GMP training plans/  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel Overview: With today's movement into more and more serious controls over food safety and security, the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...ytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing. This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that cover each  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...gulation existed. The FDA has their role and certainly must be respected. But they do not have the experience of implementing and managing quality systems. They look primarily at what or if systems exist. They do not always understand how the systems operate and interact to control all the inputs that results in acceptable and superior products. Agenda Module 1: The role of the quality  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...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 (NPRMs) by the US Department  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...ents and expectations and expound on why tracking methods must provide certain critical information about the location of a tracked device. Plus, FDA understands that manufacturers will have different tracking methods and procedures. Areas Covered In the Session: * Review the key provisions in the updated FDA guidance on medical device tracking * Understand the regulatory  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ... QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent,  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...trigger such a response by an examination / review of 101 must-have's for corporate compliance. Areas Covered in the Session: * Mandated Areas for Annual Reviews * The Master Validation Plan -- Corporate and Site(s) * Training Issues * CAPA * Trending * Facilities; Production and Process Controls * Suppliers, Contract Employees, Consultants * Some  more...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel Overview: The structure of ISO 9001: 2000 provides a focus on the processes that comprise the quality management system (QMS). Also, the general requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: *  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ...vices, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier). Once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel ...ions of missing or doubtful data, employees recognize and must follow Good Documentation Practices (GDP). These practices apply to all pharmaceutical and medical device manufacturing, and their support areas. GDP describes the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of these requirements,  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work  more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel ...s of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to another office. Beyond the use and disclosure provisions, there are requirements for allowing individuals to have access to their medical records and even asking for changes to their records or  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel ...quirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program,  more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel ...e concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes and how well it succeeds in today's highly competitive marketplace. Most important is that failure to ensure  more...

Microbiological Foodborne Threat - Risk Mitigation and Crisis Management - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...rated into a label change. Specifically, new information "must reveal risks of a different type or greater severity or frequency than previously included in submissions" and includes meta-analyses, the new regulation states." FDA requires that drug, biologics, and medical device manufacturers obtain FDA approval of their warning labels before the drugs or devices are marketed and sold.  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to  more...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or ... the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's ability to audit in a professional and knowledgeable fashion using a wide variety of hands-on activities and teaching methods. This course will  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel ...rer 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 to process capability. The presentation illustrates the statistical  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...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel ...al evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution. Sponsors need not submit a  more...

How to Survive a DEA Audit or FINDFINE - Webinar by GlobalCompliancePanel ... and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel conducts an unannounced inspection of a  more...

Managing Product Medical Device Recall Efficiently and Effectively - Webinar by GlobalCompliancePanel ...th. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly,  more...

Importing and Exporting Medical Devices A Primer on Regulatory Strategy and Requirements ...vices that have not been approved or cleared in the U. S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/ or products that emit radiation that are imported into the United States must comply with applicable U. S. regulations before, during, and after importing into the U. S. or its territories. All medical devices that are imported into the  more...

Auditing a Process-based System - Compliance Training Seminar by GlobalCompliancePanel There are a number of reasons for someone to attend this webinar. First and foremost they will gain an understanding of the process approach. The process approach requires management to identify all processes of the QMS, their sequence and interaction. They must ensure the effectiveness of all processes and the availability of needed resources, and monitor, measure, analyze and improve them. They  more...

How to Survive a DEA Audit - Compliance Webinar by GlobalCompliancePanel This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling these  more...

Leadership in Manufacturing Contamination Control ...will be presented by Teri C. Soli. The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/ sanitant qualification, water and compressed gas testing, environmental monitoring,  more...

Design Planning and conducting Effective audits GlobalCompliancePanel brings a new webinar on the topic of Design, Planning and conducting Effective audits. Webinar will be on March 23, 2010. Webinar will be presented by Mark Roberts. Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and  more...

Introduction to Professional Organizing - Webinar Discover what it takes to enter and succeed in this dynamic and growing industry. Individuals, families and companies, large and small, welcome assistance from Professional Organizers and as our industry matures, the need for more of us that instinctively know how to turn chaos into control increases dramatically. This webinar has been created to answer the many questions that must run  more...

Creating a Career Changing Personal Marketing Plan Workshop Series A true career changing marketing plan is a document that sets out in detail exactly the marketing channels that will be attacked and marketing methods that will be used; creates each marketing piece; identifies exact past history production percentages and ratios; makes projections based on past history; identifies problem areas and sets out a detailed plan to correct them; establishes objective  more...

ACT Everyday ...se replicates "a day in the life" of a busy connector who must manage a large list of customers, prospects, projects and marketing. Included in the 2. 5 hour curriculum are how to use the ACT! calendar, task list, email and letter mail merge functions, dynamic groups, company records and how to customize dashboards for a snapshot view of your action items and sales and marketing metrics. You'll  more...