Required Web-based Seminars

Data Integration for Data Mining with Talend Open Studio OS ...or the client/ server version of the tool and any support required for its installation and use. Data integration tools like Talend perform three classes of data operations: Extraction (E), Transformation (T), and Loading (L). The ETL operations included in the course are: Extraction of data from multiple input sources (tables, Excel, or delimited text files) Mapping several instances of  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...

Call Center Social Media Certification - Live Online - May 9-11 2012 ...This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring the results of these efforts. Live Online Call Center Training Our live online call center training provides a cost-effective way to maximize your training, provide virtual training in  more...

Call Center Social Media Certification - Live Online - October 3-5 2012 Social media represents one of the most significant changes in consumer media behavior in history, resulting in fundamental shifts in the way companies communicate and interact with consumers. This course provides the practical knowledge and insights required to establish objectives and strategies and to properly select the social media platforms to engage consumers, while monitoring and measuring  more...

Microsoft Word 2003 Training In this Microsoft Word 2003 training class, you will start by learning the basic concepts required to produce basic business documents. You will then learn to create more complex Microsoft Word 2003 documents by adding components such as customized lists, tables, charts, and graphics. You will also create personalized Microsoft Word 2003 efficiency tools. Finally, you will learn how to use Word  more...

Microsoft Word 2007 Training Microsoft Word is used to create, revise, and save documents for printing and future retrieval. This Word training class will provide you with the basic concepts required to produce basic business documents. You will also learn to customize and automate the way Microsoft Word 2007 works for you, to enhance your documents with customized Microsoft Word 2007 elements and to create personalized  more...

MOC 8819 - Payables Management I in Microsoft Dynamics GP 10.0 ...ing class examines the accounting cycle and the processes required to enter vendor invoices and process checks. This class also shows how to perform additional functions such as adjustments, prepayments, month-end closing, and cash flow control.A thorough understanding of these topics allows for capitalizing on vendor discount dates to reduce payable liabilities and easily select the right  more...

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 ...ing class explores the accounting cycle and the processes required to enter and ship sales orders. This class shows you how to easily manage the life-cycle of your customer ' s order from the initial quote to the shipment documentation and final invoicing. You learn how to perform additional functions setting up process holds for quality assurance and linking order documents to purchase  more...

MOC 8671 - Bank Reconciliation I in Microsoft Dynamics GP 10.0 ...ing class explores the accounting cycle and the processes required to manage cash receipts, cash disbursements, and other transactions that affect checkbook balances. This class shows you how to perform the reconciliation process, ensuring accuracy of your financial data and its relation to your financial institution.A thorough understanding of these topics allows you to reconcile your  more...

MOC 8691 - Fixed Assets I in Microsoft Dynamics GP 10.0 ... class delves into the accounting cycle and the processes required to enter, depreciate, and retire fixed assets. This course shows how to perform additional functions such as changing asset information, mass changes, partial transfers, partial retirements, and retirement undo.A thorough understanding of these topics allows companies to keep accurate records and learn to use comprehensive  more...

MOC 6419 - Configuring, Managing and Maintaining Windows Server 2008 Servers This Windows Server 2008 training class combines five days worth of instructor-led training content from the Network Infrastructure Technology Specialist, Active Directory Technology Specialist, and IT Professional Server Administrator courses of Windows Server 2008 to provide students with the knowledge and skills that are required to manage accounts and resources, maintain server resources,  more...

MOC 2261 - Supporting Users Running the Microsoft Windows XP Operating System This Windows XP training class provides students with the knowledge and skills to troubleshoot and escalate or repair problems with Windows desktop operating systems by reacting to incident requests from end users. This class will provide the basic knowledge of system architecture and security needed to provide the students with the requisite skills required to support end users and adhere to  more...

MOC 5060 - Implementing Windows SharePoint Services 3.0 This SharePoint Services class provides students with the knowledge and skills to successfully implement Microsoft Windows SharePoint Services (WSS) version 3.0 in their organizations.The class emphasizes that students should think about the architecture of their entire environment, including business and application needs, during the planning and deployment phases. The course covers how to  more...

MOC 5061 - Implementing Microsoft Office SharePoint Server 2007 ...ing class provides students with the knowledge and skills required to implement Microsoft Office SharePoint Server 2007 successfully in their organization.The audience for this class is Business Application Administrators (BAAs), Web Administrators and Server Administrators who are engaged in the planning, design, and selection of line-of-business (LOB) applications (including Office SharePoint  more...

MOC 2778 - Writing Queries Using Microsoft SQL Server 2008 Transact-SQL This Transact-SQL training class provides students with the technical skills required to write basic Transact-SQL queries for Microsoft SQL Server 2008.This Transact-SQL class is intended for SQL Server database administrators, implementers, system engineers, and developers who are responsible for writing queries.  more...

MOC 2273 - Managing and Maintaining a Microsoft Windows Server 2003 Environment ...o provide students with the knowledge and skills that are required to manage accounts and resources, maintain server resources, monitor server performance, and safeguard data in a Microsoft Windows Server 2003 environment. This is the first class in the Systems Administrator and Systems Engineer tracks for Windows Server 2003 and serves as the entry point for other courses in the Windows  more...

The Most Important Metrics For Measuring Supply Chain Performance ... a Fill Ratea the rate or quality of completing a required or set of required activities. Common fill rate metrics include: a Line Count Fill Rate a SKU Fill Rate a Case Fill Rate a Value Fill Rate These supply chain metrics, PLUS a few new metrics (like DPMO: Defects per Million Opportunities) brought to us by the Six-Sigma world, will be presented and discussed  more...

Early Intervention Field Trauma Training ... This is an entry-level program and no pre-requisites are required to receive the Field Trauma designation other than successful course completion. Participants will learn about on-site responding and learn how to respond to a critical event and aid those requiring psychological first aid. Field Traumatology explores the knowledge and skills needed to respond to the emotional trauma  more...

A Better Method for Cross Training Production Personnel ...tion organizations without significant capital investment required. This 1-hour FREE webinar will present several ideas for building a cross-training process in your manufacturing organization. Specifically, this webinar will address: a How to construct a cross-training program in operations building a successful program with little or no involvement from HR. a How to  more...

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

The Controls for Outsourcing Manufacturing and Testing - Webinar GlobalCompliancePanel The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA regulated industry will be discussed. Of course, regulatory requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance  more...

Does your Equipment Program Meet Current Regulatory Expectation - Webinar By GlobalCompliancePanel 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. Thursday, October 20, 2011  more...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel ...P) 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 the Session: What is a CCMP and how is it valuable to my company? What topics are covered in the CCMP and to what  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...

Recent Major Industry CGMP Failures and How to Avoid Them U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/ 211, and 820). They are then required to translate those regulations into procedures and work instructions.  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...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations by gcp The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish  more...

Device Changes and the 510k - Webinar By GlobalCompliancePanel The majority of medical devices are cleared for marketing in the U. S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ... support areas. Good Documentation Practices describe 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, 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  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ..., and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...t you have the proper policies and procedures in place as required by the rules and that you have been using them. This teleconference will lay out a structure for the set of policies needed and identify the topic areas that policies should include, making it easier to deal with the dozens of policy details that are required. Areas Covered in the Session: * Find out what are the  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...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 and is not needed, and how to keep it  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel ...sis / risk management and mitigation activities. 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  more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel ... under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's website and published in trade magazines, newspapers available to firms' competitors. Areas Covered in the Session: * Complaint definitions - FDA, Canada & Europe * FDA's complaint handling requirements *  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...ations affect the validation and the testing that will be required to maintain a validated state. Why should you attend: If cloud computing is so potentially important and valuable, why is it so feared? The biggest fear in regulated industries is maintaining a compliant system that is not fully controlled by the client, since the vendor is in possession of servers and software. Cloud  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...ice Directive, 93/ 42/ EEC, certification to ISO 13485 is required in most cases. This presentation is an in-depth analysis of ISO 13485 with comparisons to ISAO 9001. Areas Covered in the Session: * Principles of ISO 13485: 2003 * ISO 9001 & ISO 13485 Differences * Risk Management & ISO 14971 * FDA's MDR's & EU Vigilance * Design Control * MDD 93/ 42/ EEC &  more...

Good Documentation Practices for GMP Operations - Webinar By GlobalCompliancePanel ... support areas. Good Documentation Practices describe 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, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the Good Documentation Practices  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ...* DEA Recordkeeping Requirements: This section covers the required records to be maintained in order to comply with DEA regulations. Records include receiving/ shipping order forms and invoices, inventories, drug destructions, and theft/ loss reports. * DEA Security Requirements: This section covers the steps that a hospital can take in order to be in full compliance with the security  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ... has changed from the old rules. * The suggested and required content for a compliant 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  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * 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  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ...ts are. You will also learn about the paper trail you are required to maintain to show compliance. Compliance regulations are released by regulatory bodies throughout the product's life cycle. It is a requirement for the manufacturer of devices to ensure that the released product is in compliance with applicable laws. Areas Covered In the Seminar: * Design control defined *  more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel Overview: In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition. The purpose will be to provide medical device manufacturers with information on how to provide certification bodies with the information they need to certify products to the Third Edition in the most efficient manner. By preparing in advance for  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ements are the Risk Management Plan. As ISO 14971 becomes required for product safety certification and is audited by regulators this requirement will become a greater issue. The Risk Management Plan establishes the risk management activities required for product development, manufacturing and improvement. The plan also documents the responsibilities for various groups and positions in the  more...

Excel Spreadsheets Step-By-Step Instructions for Compliance - Webinar By GlobalCompliancePanel Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...teps of an effective investigation, what documentation is required along the way, and how to establish a comprehensive and compliant investigation system. Why should you attend: Inadequate failure investigations continue to be a major GMP deficiency cited during routine and "for-cause" inspections conducted by the FDA. While the FDA recognizes that failures are a part of business, it expects  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the recruiting process is a top priority of those in  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...re product quality. In some cases, destructive testing is required to show that the manufacturing process is adequate. End-product testing may not reveal product variations that can occur which may impact safety and effectiveness. Areas Covered In the Seminar: * What is Validation? * When should it be used? * How does it differ from verification? * Validation vs.  more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...ment 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 should attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...ution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed Rule that would amend its regulations regarding medical device establishment registration and  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...on where the action takes place * Understand what is required for the recall strategy as expected by FDA * Medical device recall authority and guidance * Depth of recall and using a viable, sustainable and effective strategy * Understand why the documentation and paper trail are so critical and termination of a recall * Discuss most recent recalls not only for devices  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ... safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools.  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...a major problem, cGMP "entropy". Proper change 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.  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel ...P) 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 the Seminar: * What is a CCMP and how is it valuable to my company? * What topics are covered in the  more...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product. Writing and executing good process validation can be a daunting task given the  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...ve actions. Includes all elements of CAPA process step as required by ISO and regulatory agencies. In addition, it is represented in a practical and proven manner which can be immediately applied in your organization. Areas Covered in the Seminar: * Module 1 o Introduction and Overview o Correction vs. Corrective Action + Understanding of all  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...This will be performed by a review of FDA-stated areas of required review and a suggested matrix format. Anticipation and addressing such on-going product modifications / changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale. Why should you attend: The FDA expects companies to perform meaningful, results driven  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...heir policies and procedures and compliance activities as required. And many may be exposing themselves to potential breaches of security because of inadequate security practices. Now there are new, increased penalties for HIPAA violations and a new auditing process is being developed so that HIPAA covered entities will be subject to reviews by the US Department of Health and Human Services'  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...ures, as well as not filing reports in a timely manner as required in the regulations. FDR considers violations of the Medical Device Reporting regulations to be serious and often issues Warning Letters to manufacturers for these violations. Areas Covered in the Session: * Review the FDA's Medical Device Reporting requirements. * Review FDA 483 MDR Reporting issues * Review  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820. 30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions. Objectives: * Know the differences between the Traditional, Special and Abbreviated submissions * Understand Substantial Equivalence and how it is  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...ticular violation. And any reports of willful neglect are required to be investigated under the law. Even violations for a reasonable cause or with reasonable diligence taken are subject to penalty. Whereas the former practice of USDHHS has been to audit compliance only in instances where a violation was reported, the law now requires USDHHS to conduct a regular HIPAA compliance audit program,  more...

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel Overview: Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure would be reasonably likely to have serious adverse health consequences,  more...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel ...ct 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, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices. Why should you attend: There are certain circumstances in which a report from the field requires  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...uture. This will be performed by a review of 101 areas of required review or industry problem areas. The result will be a basis for such a management review and a listing of likely milestones and tasks. Anticipation and addressing of weak spots proactively will further prove a company is "in control", assist in timely review of submissions to the Agency, and in any remediation efforts. Why  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ...I device, a less complex CE Marking Technical File may be required. In the case of Class IIa, IIb and Class III devices, 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  more...

Know Your Customer - The DEA Due Diligence - Webinar By GlobalComplaincePanel This training will cover several recommendations to improve Due Diligence when distributing Schedules II through V controlled substances and regulated chemicals to your customers and what steps can be taken to prevent the illicit use or diversion of any product sold to a customer. As a firm handling these products, you will get a better understanding of what is required from a DEA registered  more...

Good Documentation Practices in a Regulated Environment - Webinar by GlobalCompliancePanel ...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, recognize their significance to their job and be aware of the consequences of non-compliance. During this 1-hour webinar, we will review the applicable US and EU  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 ...required in a number of areas of the HIPAA regulations and their policy implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures 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  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel To satisfy QSR and ISO 13485 requirements 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  more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel ...required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and Health Canada. This webinar discusses how  more...

BRC Risk Analysis - Webinar by GlobalCompliancePanel Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. This presentation will take you step by step through the creation of each type of risk assessment required by the BRC. Process and  more...

Supplier Evaluation and Assessment How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner - Webinar by Global ...required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel ...ss of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and  more...

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

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel ...irements for meeting Food Safety and Quality standards as required by BRC fundamental clause 5. 0, SQF item 4. 5, 9 CFR will be covered. The purpose of traceability and its value to the brand will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer perspective will be shared  more...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel ...l study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel ...required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and Health Canada. This webinar explains the  more...

The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel .... Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring  more...

A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines.  more...

Change Control and Logging in the PCI environment - Webinar by GlobalCompliancePanel Change control in IT environments has been a focus for a decade or so, especially for application changes. In this webinar you will learn: The components of a strong change management program, including specifics on configuration management, system hardening, and compliance review. In addition, the types of logging and monitoring required by the PCI DSS will be discussed which will enable  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...

ITIL Foundation Bridge Virtual Classroom Take the ITIL ® v3 Foundation Bridge course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This 2-day course introduces learners to the lifecycle of managing IT services to deliver to  more...

ITIL v3 Foundation Virtual Classroom Take the ITIL ® v3 Foundation course Virtual Classroom is set up in the same manner as the physical classroom however altered to optimize the virtual learning experience without the hassle of travel. The virtual classroom delivery option is ideal for training geographically dispersed teams. This exciting and dynamic 3-day course introduces learners to the lifecycle of managing IT services  more...

Process Instrumentation and Control Online Certificate Course The online certificate program in Process Instrumentation and Control (I&C) consists of three modules covering the different phases of I&C from a nonmathematical and practical point of view. It includes basic concepts, engineering, and installation of control equipment. The attendees will learn about: 1. Basics of I&C, including different control functions, types of control loops, and  more...

Communication Skills in the Workplace It is well known that before you come to work, you have to leave your casual self back home. In the office, you're an employee, someone who's supposed to go about his/ her work in the most professional manner. There is a way to talk to your superiors, to your peers and your subordinates. This method of communication is known as workplace communication and is typically formal and to the point. So  more...

WordPress Training These are online one to one training sessions that will take you through how to use WordPress for your website. This is using WordPress. org and can be used for WordPress. com if requested. The delegate will share the trainers computer and is required to work through tasks and can request specific topics such as how to add ecommerce to their wordpress site.  more...

Complete Java Training ...s exercise * Instructor-led Live training Software required for Training * All the open source softwares are provided as part of Training * A computer with internet connectivity. * Operating system that supports Java 1. 5. 0 or later * Eclipse 3. 2 * My SQL 5. 0 ================================================ Java EE Introduction training * Java EE Overview *  more...