Issues Web-based Seminars

Data Manipulation Techniques ...., excel, use the ODBC, etc); Clean data and address such issues as missing data, duplicate entries, outliers; Reshaping, aggregating, merging data; Performing such tasks as looping, vectors, beginning automations with macros specific to data manipulation. Primarily syntax will be used, but where helpful to those learning syntax, some GUI interface will be utilized as well. Application in  more...

LABOR RELATIONS TRAINING ...onment, all of a sudden have to deal with labor relations issues for the first time. We will assist your managers in dealing effectively with the labor relations process and will provide an in-depth review of your current collective bargaining agreement in terms managers can understand. We will cover concepts such as progressive discipline, effective handling of sick leave and tardiness  more...

LEGAL LANDMINES EXEMPT VS NON-EXEMPT CLASSIFICATION ISSUES Dona ™t get caught by the Department of Labor for misclassification of your employees! Attend this informative and engaging on-line live webinar today to learn key methods to avoid FLSA liability for misclassification of employees. This webinar will be presented by an experienced employment attorney who will provide an in-depth summary of what you need to know and answer all your FLSA and  more...

Top Tips To Prevent Workplace Violence in your Workplace ...onsulting on a wide range of workplace and human resource issues. Ms. Fleischer is a management-side employment attorney with over twenty (20) years experience and is nationally recognized as an expert in her field. She has successfully represented numerous clients in employment discrimination litigation as well as providing preventive counseling and training on workplace issues. Ms.  more...

Employee Handbooks Dos and Donts ...book. It will examine what the courts have said on these issues and provide practical tips on avoiding liability in the future. Learning Objectives a How to protect your company from the top mistakes that employers make in drafting employee handbooks a How to prevent claims of implied contract a How to avoid using language that can give rise to claims of breach of implied  more...

Top Tips For Managers to Prevent Harassment in your Workplace The best 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  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...

MOC 5051 - Monitoring and Troubleshooting Microsoft Exchange Server 2007 This Exchange Server 2007 training class teaches messaging specialists to monitor and troubleshoot an Exchange Server 2007 messaging system. Students will learn how to correlate client and server issues and resolve those issues. They will also learn how to monitor systems and create reports from the monitoring data.  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...

Business Ethics Training ...tivities also cover identifying common managerial ethical issues, being proactive with ethical issues, addressing subordinates ' ethical issues, identifying causes of unethical behavior, recognizing unethical behavior, and ending unethical behavior in the workplace. Students will also learn about organizational ethical principles, and the four categories of corporate social responsibility.  more...

Project Management Training ...environmental, socioeconomic and organizational structure issues, and the responsibilities of a project manager. Course activities also cover defining the project scope, writing a project charter, developing a work breakdown structure, identifying time management components, describing schedule development, using mathematical analysis techniques, and assigning resources. Students will also  more...

MOC 6425 - Configuring and Troubleshooting Windows Server 2008 Active Directory Domain Services This Windows Server training class provides Active Directory Technology Specialists with the knowledge and skills to configure Active Directory Domain Services in a distributed environment, implement Group Policies, perform backup and restore, and monitor and troubleshoot Active Directory related issues.The primary audience for this training class are AD Technology Specialists, Server  more...

MOC 5928 - Managing Projects This Microsoft Project training class provides students with the knowledge and skills to initiate, plan, execute, monitor and control, and close enterprise projects by using the Microsoft Office Project Server 2007 enterprise tool.This is the second class in the Microsoft Office Project 2007 Official Curriculum series and covers the Microsoft Enterprise Project Management (EPM) Solution.This  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 ...-reducing behaviors. Specific performance measurement issues we will address in this montha ™s important a Global Manufacturing Enterprise Seriesa webinar include: - What is the best way to organize the procurement function when so many items are sourced globally? - How to define purchasing behaviors to better leverage global supply-chain opportunities. - Ideas for building  more...

JIRA Fundamentals Training Course Course Summary The JIRA Fundamentals training course provides the ideal jumpstart for your team to use JIRA more effectively. The material covers all features of the product from an end-user's perspective, and provides a solid foundation for users with all levels of experience, since it explains the most effective ways to use JIRA and some handy tips for getting the most value out of the  more...

How to Achieve Maintain ERP Systems Master File Data Integrity ...important webinar focuses on the following THREE critical issues that can ultimately determine the effectiveness of an integrated information systems environment: 1. How to measure, monitor and report the completeness of master file data and system operating parameters. 2. How to measure, monitor and report the accuracy of key master file data elements, and 3. How to measure,  more...

Standards of Trauma Care Attachments systems and context ...amines age, gender, race, culture, social class, systemic issues, community standards of care, and other factors that are important in designing and implementing programs to fit client needs with appropriate treatment. OBJECTIVES: Clinical Standards of Trauma Care goal is to train the traumatologist to develop an understanding of the practical applications of trauma practice, research, and  more...

Operations Improvements Monthly Webinar each month on the 3rd Thursday, this Webinar series addresses one or more SPECIFIC issues facing OPERATIONS professionals in the maufacturing and distribution industries.  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...

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...

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...

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...

Meeting Annual US FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel There is an on-going major shift in the emphasis of U. S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...ts have typically been overlooked while gaping compliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the required contamination control elements to ensure easy compliance. A CCMP defines to your organization, as well as to auditors, how you mitigate the risks of the specific contaminants for your products. Areas Covered in  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ... auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based Part 11 software verification and validation activities. Simple but effective and real world 21 CFR Part 11 software V&V is even more important in todaya ™s resource constrained industrial environment. Areas Covered in the  more...

Requirements of validation and control of EO Sterilization - Webinar by global compliance panel Sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...iation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness. Why should you attend: Radiation sterilization validation is a topic that results in many audit observations from the FDA and  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...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...actical workshop address both the legal and psychological issues that often arise, such as confidentiality, fitness for duty evaluations, when and why to drug test, the relationship between conduct problems and mental illness, and how to directly address mental health problems with managers and employees. Why you should attend: Rrisk of litigation if psychiatric disabilities aren't handled  more...

Dress Code Nightmares How to Deal with them and How to Prevent them by TrainHR This practical webinar teaches HR professionals and small business owners how to avoid harassment or discrimination claims that can arise from poorly handled - or inconsistently enforced - dress code issues. It provides specific guidance on how to talk about some of the most difficult topics there are - body odor, inappropriate dress, an unkempt appearance, etc.  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 Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Human Behavior in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel his live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans. The key benefits of this course are: In-dept understanding of cleanroom contaminants. Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances.  more...

Understanding good Closed Loop CAPA system - Webinar By GlobalCompliancePanel This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/ preventive actions to prevent the repetition of these occurrences in the future. Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ...ormation systems and flows to be assessed for risks. Risk issues and recommendations for each system or information flow can then be described and organized into a table that is used to define the risks and prioritize their mitigation, using a straightforward high-medium-low stratification of potential likelihood and impact for each risk issue, following the risk determination method identified  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...ader will help you identify key regulatory and industrial issues associated with API manufacturing. You are purchasing more than a chemical or biological material. You are purchasing a material that can carry with it hidden risks if not properly examined and controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ... auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based software verification and validation activities. Effective and real world software V&V is even more important in todaya ™s resource constrained industrial environment. Areas Covered In the Session: * Verification or  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ... It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/ or preventive actions, and do proper impact analysis / actions. As such RCA is a major element of cGMP compliance, and is also a key source of regulatory problems. How can companies  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ke appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel ...he 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 for the switching  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...ed and corruption of hard copy validation evidence. These issues are prompting life-science companies to search for ways to streamline and centralize their validation projects. When deciding on whether or not a Test Management Tool should be implemented, companies need to realize that the implementation of the Tool will be similar to an implementation of any regulated application, therefore  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ... * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily. * Minimize nonconformances. * Reduce rates of batch rework and rejections. * Avoid product recalls. Why should you attend: Since humans are the major source of contamination in cleanrooms, special care must be taken to choose and provide proper garments to  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ... * Reduce cleaning-related environmental contamination issues. * Avoid product recalls. * Understand industry standards in cleanroom cleaning Why should you attend: Cleanroom cleaning processes and methods have been scrutinized by FDA auditors due to their important role in cleanroom management. Poor or substandard cleaning can result in manufacturing delays, nonconformances,  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...nt business associate agreement will be presented. * Issues of how to assign liability and costs in the event of a breach will be discussed. * Current BAs will learn what they have to do to get their contractors established as their business associates. * BAs will discover the new obligations on them to ensure their clients comply with HIPAA in their dealings with the BA. *  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...crease the likelihood of your internal audits identifying issues that the inspector will see is to arrange your internal audit scheme to mimic the process the FDA inspector will use. If you perform your internal audits this way, you'll be well prepared for the FDA. Areas Covered In the Seminar: * History of FDA inspection methodologies, from haphazard to QSIT. * Anticipate and  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive, companies need to reevaluate their vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners". Why you should attend: The last few years have  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ... product clearance and approval, while reducing liability issues. Why you should attend: The U. S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ... control is required to resolve any underlying compliance issues or product problems that are increasingly seen by regulatory agencies and consumers worldwide. To meet this new regulatory climate and be competitive, companies need to continually reevaluate their change control system and its impact on all areas of a companya ™s cGMP activities. Why you should attend: The last few years  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...eview. Areas Covered in the Session: * Key cGMP issues * Avoid complacency from past "good" FDA/ ISO audits * The desired response * How to respond now -- where to shift focus first * Where to direct scarce resources; A risk-based phased approach * How to address known problem areas during an Audit * Prove 'in control' * Maintain 'the edge' Who  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...t the requirements for electronic records and some of the issues these requirements raise. We also examine the current guidance document on electronic records and explain where FDA will exercise "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  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...ts have typically been overlooked while gaping compliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the required contamination control elements to ensure easy compliance. A CCMP defines to your organization, as well as to auditors, how you mitigate the risks of the specific contaminants for your products. Areas Covered In  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...ght. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...osal; Prevention of Thefts and Losses; and other security issues. * Review DEA requirements pertaining to the filling of controlled substance prescriptions. This includes electronic prescriptions, a 90-day supply of a Schedule II drug, and prescriptions written for opioid dependency patients. Who Will Benefit: Most participants of this presentation are pharmacists, pharmacy students,  more...

Labeling Requirements for Dietary Supplements - Webinar By GlobalCompliancePanel ...issues including misbranding that are eating into profitability of dietary companies. The webinar teaches the attendee how to avoid common labeling compliance issues including: * Misbranding * Misleading claims * Misleading statements * Directions of use The webinar focuses on general labeling provisions for dietary supplements, requirements for inner and outer  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ... program. Areas Covered in the Session: * Legal issues from the public's perspective * Legal issues from the organization's perspective * HIPAA issues impacting social media marketing * "Spam" issues * Advertising rules * Content ownership and control * Potential SEC issues relative to social media marketing * Company-sponsored blogs versus outsider  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...nufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are concerned that manufacturers have not placed adequate attention to following these regulations, which they consider to be primary indicators of safety issues and therefore very important to the public  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...stions * Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session Who will benefit: This course is appropriate to those involved in all aspects of the premarket notification, i. e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ... * Understand the impact with user facilities and patient issues Who Will Benefit: This webinar will provide an overview and guidance to device manufacturers involved in medical device tracking activities. Employees who will benefit include: * All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the Medical  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...te 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 regulatory agencies. The course will also discuss how personnel can best address the conflicts that sometimes arise and the  more...

FDA 483 Observations in the Laboratory What went wrong How can they be avoided - Webinar By GlobalCompliancePanel ...y control system. Laboratories should proactively address issues of concern 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 *  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do internally. A review of recent information  more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel ...any'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 and how  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...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...ke appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The statement clearly reflects the renewed FDA interest in examining industry compliance with regulations for electronic records and electronic signatures - and its willingness to aggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar  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...

Regulatory Complaint Handling MDRs Recalls - Webinar by GlobalCompliancePanel ...tandable terms. Many medical device firms face regulatory issues as a result of inadequate complaint handling. FDA has explicit complaint handling requirements and poor complaint & reporting procedures often result in costly recalls and warning letters. FDA warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firm's competitors, and  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...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part ...r that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous  more...

Update on Unique Device Identifier for Device Manufacturers FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely  more...

FDA Compliant HPLC Qualification and Performance Testing GlobalCompliancePanel brings a new webinar on the topic of FDA Compliant HPLC Qualification and Performance Testing. Webinar will be on March 4, 2010. Webinar will be presented by Dr. Ludwig Huber. Mr. Huber is Director of Lab compliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Lab compliance, the global on-line resource for validation and  more...

Maintenance Management Online Certificate Course ...vices clients of all sizes on a wide range of maintenance issues. Participants in this training program will learn: * When to outsource * How and when to in-source * Planning and scheduling maintenance jobs to improve productivity * How to make PM (Preventive Maintenance) work for you * Ideas to manage the stockroom * How to improve uptime * How to insure the PM tasks are  more...

Working with Seniors - On-Demand Webinar Prepare to tap into the fastest-growing market in the world. Working with Seniors is all about relationship-building. This webinar focuses on the world as Seniors see it and examines the issues they deal with every day. Surfing the Age Wave! will help you understand their unique perspective and provide the necessary tools for relating to them. Gail Shields is a Move Organizer Extraordinaire and  more...

Complete Java Training ... Hibernate Training * Introduction to Hibernate * Issues with Persistence layers and Object-Relational Mapping (ORM) * Hibernate architecture overview * POJO (Plain Old Java Object) Based Mapping * Configuring Hibernate o hibernate. cfg. xml file/ hibernate. properties o SessionFactory configuration o Connection properties, Configuration class, Session Interface *  more...