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Data Mining for CRM using STATISTICA Data Miner This course introduces you to the area of customer relationship management (CRM) and the STATISTICA Data Mining10. 0 interface. You are introduced to the different learning methods of parametric statistical analysis and data mining analysis, and introduced to the practice of combining several modeling algorithms (ensembles) to predict customer responses. The methodological emphasis of this course  more...

Live Online Course for gaining PDUs Towards the advancement of Project Management knowledge, after acquiring PMP Certification you require continuing the certificate (CCR).Certificate is valid for 3 years & 60 professional development units (PDUs) are required during each three-year certification/ CCR cycle. PMSoft provides facility to earn PDUs through Free Live, Online PDU Sessions on various topics related to Project,  more...

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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...

MOC 6231 - Maintaining a Microsoft SQL Server 2008 Database This SQL Server training class provides students with the knowledge and skills to maintain a Microsoft SQL Server 2008 database. The class focuses on teaching individuals how to use SQL Server 2008 product features and tools related to maintaining a database.This SQL Server 2008 class is intended for IT Professionals who administer and maintain SQL Server 2008 databases.  more...

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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 2780 - Maintaining a Microsoft SQL Server 2005 Database This SQL Server 2005 training class provides students with the knowledge and skills to maintain a Microsoft SQL Server 2005 database. The course focuses on teaching individuals how to use SQL Server 2005 product features and tools related to maintaining a database.This class is intended for IT Professionals who want to become skilled on SQL Server 2005 product features and technologies for  more...

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MOC 2779 - Implementing a Microsoft SQL Server 2005 Database This SQL Server training class provides students with the knowledge and skills to implement a Microsoft SQL Server 2005 database. The course focuses on teaching individuals how to use SQL Server 2005 product features and tools related to implementing a database.This training class is intended for IT Professionals who want to become skilled on SQL Server 2005 product features and technologies for  more...

JIRA Workflow Administration Webinar The JIRA Workflow Administration training course covers all administrative features of JIRA related to customisation of the workflow and data capture. Attendees from this session will become proficient with creation of custom fields, new issue types, workflow statuses, transitions, post functions, field configurations, mandatory fields, hidden fields, workflow schemes and applying a JIRA workflow  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities ...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, and the extension of the accounting out to them by way of their use of Designated Record Set data will be explored, including potential necessary changes to business associate agreements. Learn how the new  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...

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...

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...

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...

Statistical Applications - 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.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...nciples, core requirements of the ISO standard as well as related standards and guidance. We will define how radiation 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:  more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen ...s, while presenting a fresh new approach to these key and related documents. Why you should attend: Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices - which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing  more...

CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old  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...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ...m you during your DHR review. * How QSIT inspections related to record keeping is performed by FDA. * How Change can affect DHRs. * Learn what constitutes a good DHR procedure. * Learn how risk management fits into DHR compliance. * Learn how to better audit quality record systems. Areas Covered in the Session: * Introduction * Guidance documents/ QS  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel ...cleanroom garments and their use. * 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  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel ...es of batch rework and rejections. * 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  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...in a cost efficient manner * How to perform supplier-related corrective action * Minimum documentation requirements for supplier qualification, assessment, and related corrective action Who will benefit: This webinar will provide valuable assistance to all regulated companies that are interested in implementing a supplier management program that is both compliant and  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel Overview: This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you  more...

Introduction to Investment Risk - Credit Market and Portfolio - Webinar by GlobalCompliancePanel ...ent * Appreciate the limitations of Alpha, Beta, and related tools * Avoid the Landmines of Portfolio Management PART THREE * Differentiate the Major Types of Credit Risk * Calculate Expected Losses * Grasp the Pivotal Role Basel II and Basel III Plays in Global Banking * Consider Sovereign Risk in Investment Decisions Who will benefit: * High Net  more...

Asterisk telephony Infrastructure setup Design & build telephony infrastructure using Asterisk. Agenda: 1. Introduction to Telephony 2. Understanding IP telephony 3. Understanding traditional PBX and Soft PBX. 4. Overview to Asterisk & related products. 5. Installing AsteriskNOW 6. Installing Elastix 7. Adding basic components - extensions, trunk, outboundroute etc., 8. Working with Ring groups, VoiceMail & IVR. 9.  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...s webinar 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. The seminar begins with Excel methods to help ensure the spreadsheet produces the results you want.  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...it o CAPA and responses for the audit findings related to Part 11 - what to expect and handle the difference between 'regular' audits and Part 11 audits o Some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit * Module 4 - Audit Trails o Types of audit trails o Strategies for  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa Overview: Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority. By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel Overview: This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the  more...

Legal Risks in Social Media for Healthcare Providers - Webinar By GlobalCompliancePanel ... with which they can use social media tools, particularly related to HIPAA and other medical privacy concerns. However, it is possible to pursue a social media strategy while abiding by the legal and ethical constraints on healthcare industry participants. This seminar will address the social media environment applicable to healthcare practitioners, the relevant restrictions, the sources of  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to learn which of your "rules of thumb" are actually quite wrong! Perhaps  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...ned as a "systematic and independent examination of trial-related activities and documents" that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...weeks and months the FDA will conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel ...tization practices * Debunk a few water system myths related to sanitization Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA, EMA, and AAMI regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies.  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel Overview: This Webinar will provide a substantive overview and outline differences between the Technical File and Design Dossier for those device firms dealing with the global regulatory landscape. It is assumed that participants and customers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details  more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel ...ber 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 asking to have special restrictions placed on their  more...

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

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...om 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies but industry needs more guidance and  more...

Outsourced processes and ISO 90012008 - Webinar by GlobalCompliancePanel In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part ...the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11. FDA made it very clear 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  more...

New Requirements for the Medical Device Directive MDD GlobalCompliancePanel brings a new webinar on the topic of New Requirements for the Medical Device Directive (MDD) Webinar will be on March 11, 2010. Webinar will be presented by Albert Cefalo. Mr. Cefalo has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career  more...

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems GlobalCompliancePanel brings a new webinar on the topic of Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems. Webinar will be on March 11, 2010. Webinar will be presented by Teri C. Soli. Mr. Soli has 25 years of diverse "Big Pharma" operating company experience. During his 30 year career he has lectured extensively at conferences, authored numerous papers and  more...