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Documentation Training Seminars and Classes

From Sql Server Online Training

MSBISSIS SSAS SSRS 2012 Online Training SQL School SQL School, one of the best places for SQL Server PRACTICAL training provides Microsoft business intelligence [MS BI] course with one REALTIME PROJECT. Course Duration is for minimum of 70 hours, completely practical and covering SQL Server Integration Services [SSIS], SQL Server Analysis Services [SSAS] and SQL Server Reporting Services [SSRS]. Please find the Course Highlights: SSIS a more...

From Requirements Solutions Group

How to Find and Build Test Cases from Business Requirements

Test cases are situations taken from real life that will put a new or modified information technology solution through its paces. Business test cases should be designed to find existing errors and to increase your confidence in the applicationa ™s ability to survive the real world of production. The key to a successful suite of test cases is to use a wide variety of methods to discover and more...

How to Define and Document Use Cases

A business use case diagram is a visual tool that shows interaction between the environment and an evolving information technology solution. A single business use case is a textual tool for representing how individual end-users and other involved parties or systems (collectively referred to as "actors") will interact with the proposed system. Knowing why you need a business use case, when it more...

How to Manage Changing Requirements

Managing requirements change has been a major challenge even for the best-run projects. Keeping track of how the changing business environment impacts ongoing projects and production applications can be a nightmare without proper tools and techniques. The concept of requirements management is not new but with an increase in the use of off-shore developers and off-the-shelf solutions, it has become more...

From THOMAS HOUSTON associates, inc

EMPLOYEE DOCUMENTATION AND RECORDS RETENTION Various OFCCP regulations require that contractors preserve complete and accurate personnel records and to permit the OFCCP access to their records, including computerized records, for inspection and copying. Upon completion of this program the trainee will have an understanding of: The different OFCCP regulation retention period requirments When / how it is permissible to transfer more...

From Future Media Concepts

Adobe RoboHelp 7 - Online ... a help system for an application? Maybe you're part of a documentation services team, and would like to enhance the appearance and functionality of help systems using advanced techniques. Learn to use Adobe RoboHelp 7, the authoring tool with advanced features that assists you in creating such projects. In this course, you will work with RoboHelp to create an advanced help system. You will more...

From HR Learning Center LLC

TOP TIPS TO AVOID LIABILITY WHEN FIRING EMPLOYEES

This live on-line webinar will provide all the information your managers need to know to prevent liability when terminating employees. HR Learning Center will provide tips on providing documentation to support your termination decision and avoid claims of discrimination when terminating empoyees. We will also provide information on ways to avoid claims of wrongful discharge and breach of implied more...

From Webucator

MOC 8824 - Sales Order Processing in Microsoft Dynamics GP 10.0 ...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 orders.A thorough understanding of these topics allows you to boost sales order processing productivity and help improve customer service by automating sales order more...

From GlobalCompliancePanel

Good Documentation Practices for GMP Operations - Webinar GlobalCompliancePanel Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices. Wednesday, July 11, 2012 10: 00 AM PDT | more...

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

Efficient Computer System Validation - GlobalCompliancePanel Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Tuesday, May 15, 2012 10: more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar GlobalCompliancePanel Overview: RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. Tuesday, April 17, 2012 10: 00 AM PDT | 01: 00 PM EDT more...

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

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

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

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

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

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

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

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

A Practical Look at Discipline and Termination - Webinar By TrainHR This webinar takes a practical look at discipline and termination as part of effective performance management. You'll learn about different kinds of discipline policies and some of the legal implications of using discipline. You'll also explore some best practices for deciding: when and what kind of discipline to use, how to document it, and how to implement it. Importantly, you'll also look at more...

Corporate Integrity Agreements Offer A Second Chance - Webinar By mentorhealth Health Care Providers that find unintentional coding or documentation errors and report them to their Medicare Contractors or Intermediaries or private payers should not worry about being subject to CIA's. Thursday, October 27, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

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

HIPAA Privacy Policies and Procedures Prepare for Updates and New Requirements - Webinar By mentorhealth Learn how having good policies and procedures and good documentation can make compliance easier. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT 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...

The DHF DMR DHR and the Technical File Design Dossier - Regulatory Requirements - Webinar By GlobalCompliancePanel This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR. Wednesday, November 2, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

Software Verification and Validation Planning to Meet FDA Requirements - Webinar By GlobalCompliancePanel The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. Wednesday, October 19, 2011 10: 00 AM PDT | 01: 00 PM EDT more...

The 510k Process Risk Management - By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products. more...

The 510k Process Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products. more...

The 510k Process and Risk Management - Webinar By GlobalCompliancePanel This webinar will discuss FDA concerns in medical device safety expressed in reports on 510(k) products. more...

From ZaranTech.com

Business Analyst Competency Development Program

...sis Tools - MS Visio & Enterprise Architect 10. Project Documentation and Management 11. Software Testing 12. Overview of International Institute of Business Analysis (IIBA) ®, Business Analysis Body of Knowledge (BABOK) ®, Certified Business Analysis Professional (CBAP) ® 13. Requirement Gathering, Analysis and BRD creation in Real World domains, such as Financial, Health more...

From GlobalCompliancePanel

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ... that is supporting the company's Quality System and cGMP documentation. It will assist in evaluating software vendor claims to separate compliant software from "vaporware". A manufacturer is responsible to identify these requirements and implement them into an effective 21 CFR Part 11 CGMP software V&V process. Why you should attend: Software has become pervasive in medical product 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...

Residual Risk and Risk based Verification Learn how define the residual risk of your device and how to streamline the verification process by employing a risk based approach. more...

Design Planning and Conducting Effective Audits - Webinars by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement. more...

Design Planning and Conducting Effective Audits by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement. more...

Validating Radiation Sterilization for Medical Device Industries by gcp Gamma and E-Beam radiation has used for sterilization of medical devices for over 50 years. Both methods are validated following the same principles and standards. This webinar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1: 2006 and ISO 11137-2: 2006. In this one more...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations more...

Risk Assessment - Compliance Using Easy To Fill Out Documentation BY GCP This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance more...

Breakthrough Performance Management that is Practical Effective and User-Friendly ...vered on the appraisal instrument. Ratings are useful for documentation, but do not help with performance improvement. Areas Covered in the Session: Performance Management How to Give Feedback Coaching Counseling How to handle personnel problems How to improve performance of subpar employees How to define good performance How to develop employee more...

Effective Employee Performance Documentation Elements and Techniques by TrainHR ... legal challenges by producing more effective performance documentation. Employees are more productive when they know what is expected of them. Employee discipline is easier when documents are in order, and high standards are met when directions are clear. Learn simple, stress-free methods for collecting the right information, keeping the right records, and tracking performance outcomes. more...

Root Cause Analysis and Documentation Requirements for CAPA - Webinar By GlobalCompliancePanel RCA is a popular topic and many companies realize its importance in correcting problems. However, there is still much confusion and many problems continue to recur. This webinar will use thoughtful discussion, humorous analogies and case studies to distinguish between the true root cause and other common imposters. Emphasis will be placed on realizing system interactions and cultural more...

How to Create Configure and Manage a Design Inputs - Design Outputs Traceability Matrix utilizing the principles of Lean Documen Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while more...

Creation and management of a Controlled Document System for a Life Sciences manufacturing plant utilizing the principles of Lean Controlled documents are one of the foundational building blocks of a Quality Management System (QMS) for regulated industries. Too often, controlled documents are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to this key part of a QMS. more...

Master Production Record Requirements - Webinar By GlobalCompliancePanel This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records. The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...t begin at $10, 000. We will discuss what information and documentation needs to be prepared in advance so that you can be ready for an audit without notice. Sample information request forms and questions asked at prior audits will be presented. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your more...

Good Documentation Practices for Laboratory Operations Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...Part 211 and Eudralex, Volume 4) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and 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 more...

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

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ... * Learn how having good policies and procedures and good documentation can make compliance easier. * Learn the set of policies that need to be included in four groups of policies: Information Security Management Process, Acces Controls, Data Management, and the Information System User Policy. * Learn how to use your policies and procedures, and the documentation of use of your more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...ltiple regulatory requirements and will learn the role of documentation in showing compliance and assisting in the information security management process. Having good policies provide the foundation of good practices and compliance - we will discuss a set of topics that should be covered in a good set of information security policies meeting HIPAA and PCI requirements. Areas Covered in the more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...tion and maintenance, and those who have involvement with documentation. The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel ...st of components", the session will cover attachments and documentation expectations. Finally, the webinar will review the process and requirements for issuance and handling of Batch Production Records (BPR), and clearly describe the difference between the master and the batch production record. Why should you attend: All the requirements for the master production record (MPR) are based on more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel Overview: As anyone that has been involved in a traditional paper-based validation project can attest to the ability to manage the validation deliverables, timelines, resources, tasks and the compliance of the project can be difficult, resource extensive and time consuming. Most paper-based validation practices require many documents that are managed both electronically (in multiple systems) more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...lification categories A, B and C * Qualification and documentation requirements for each category * Going through the category example list * Approach for existing systems * Approach for automated systems (incl. firmware/ computer systems) * Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade) * Documentation requirements more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ...cted late in the product development process is largely a documentation exercise - rarely does this FMEA affect the design. Emphasis is placed on enhancing the power and benefits of FMEA for your organization by avoiding common pitfalls and concentrating efforts toward the real value of the FMEA process. Areas Covered in the Session: * What is an FMEA o What are the more...

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

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...uirements for resources, and outline the expectations for documentation review. Additionally, the course will look at the creation of disposition packages for approval and rejection of materials, and cover changes in disposition status. The course will not cover the disposition of raw materials, third party (CMO) manufacturing, or validation lots. Why should you attend: The process for more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel Overview: When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...each Notification Policies o The Importance of Documentation * Enforcement and Audits o New HIPAA Violation Categories and Penalties o Preparing for HIPAA Audits o Case Studies Who will benefit: * Compliance director * CEO * CFO * Privacy Officer * Security Officer * Information Systems Manager * HIPAA more...

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel ...ntation 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 certification reviews and more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...ical methods for meeting the requirements. Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product, important characteristics of the Risk Management Plan must be documented to meet requirements. In 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...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel ...ar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project. Areas Covered in the Session: * Learn more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...cess from failure identification and notification through documentation. Participants will review root cause analysis techniques and observe how to identify corrective and/ or preventive actions towards successful remediation and closeout. This high-level overview will provide clarification on the steps of an effective investigation, what documentation is required along the way, and how to more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well. Why you should attend: Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. You need to be aware of how design control applies to your device(s). It's apparent many firms are not: more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...ndees will also learn how to maintain adequate validation documentation systems and perform equipment qualifications and process validations, and evaluate the need for re-validations. Why you should attend: The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with process validation. Regulators believe more...

Purchasing and Supplier Controls in the Medical Device Industry - Webinar By GlobalCompliancePanel ...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 cost-efficient. The employees who will benefit include: more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel Overview: This interactive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as 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 ...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 reliability of the generated data which is required for critical for go-no-go decisions. An effective Equipment more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel ...tainable 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 but pharmaceuticals and why the numbers are alarming * Review recent statistics and trends Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms that are more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of 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 more...

Cleanroom HEPA Filter Testing Certification An Owners Guide - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on identifying and discussing testing and certification requirements associated with cleanrooms. The key benefits of this course are: * In-dept understanding of industry standards, processes, and criteria for testing cleanrooms and HEPA filters * Achieve satisfactory inspections more easily * Higher assurance of new medical product approvals more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...tion due to the need for excessive validation testing and documentation. This, in turn, can lead to lengthy and sometimes fatal delays for roll-out to production. How can such systems be validated in an efficient manner and with a level of documentation commensurate with actual regulatory risks? The key is to plan for validation at the beginning of the project with a fundamental focus on more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ... terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management * Planning and Realization of Safe Products a flow diagrams, process steps and control measures * Hazard Assessment - Control Measures * Design and Redesign of HACCP Plan a Critical control points * Verification * Corrections and more...

Hazard Analysis vs FMECA Differences and Commonalities - Webinar By GlobalCompliancePanel Overview: The terms "Hazard and Risk Analysis" and "Failure Mode, Effects and Criticality Analysis (FMECA)" are often used synonymously. However, there are significant differences in both methodologies and their strengths can be combined to ensure a safe and efficacious system design. The presentation will explain both methodologies and will show ways how these tools can be used to complement more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...esponsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the regulations and citations), attendees will be able to envision what to include in a GMP training program. In addition, an overview of the training system, including types of training planning, will offer considerations to make GMP more...

Electronic Raw Data in Regulated Environments - Definition Recording and Archiving - Webinar By GlobalCompliancePanel Overview: All regulations have strict requirements for electronic raw data and other e-records. The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA's 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ..., and training of all functions. Module 3: Management of Documentation and Records Module 4: Design Control Module 5: Facilities, Equipment & Environment Module 6: Material a Purchasing Controls-Specification, Qualification and Control of Suppliers, and controlling incoming materials Module 7: Technical and "Administrative" Process Controls Module 8: Introduction to Deviations & Quality more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the 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...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel Overview: Within the next few 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 more...

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

Full Day Virtual Seminar - Reduce Software Validation Costs and Pass the New 21 CFR Part 11 Inspections - Webinar by GlobalCompl This interactive one-day seminar details how to reduce costs associated with implementing, using, and maintaining computer systems in regulated environments. Nearly every computerized system used in laboratory, clinical, manufacturing and the quality process has to be validated. Participants will learn the latest techniques for complying with 21 CFR Part 11 that greatly reduce software more...

Computer System Validation Step-by-Step - Webinar by GlobalCompliancePanel Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, structure of validation report. more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel ...ories that work in a GMP environment are 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 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...

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel Product traceability requirements 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 more...

Defining and Managing Protocol DeviationViolationException - Webinar by GlobalCompliancePanel ...What is the approach to predict and prevent it. Proper documentation and reporting of PNF as they occur is helpful for investigators and study sponsors, as these data can be used to determine the need for amendments to the protocol and/ or the related documents. The monitoring of the frequency and nature of PNF can also be used as a quality assurance measure for the site. A noncompliance more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel ...ories that work in a GMP environment are 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 more...

Proper Use of Risk Management Tools for ISO 14971 Medical Device Safety - Webinar by GlobalCompliancePanel In this presentation we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device. During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give more...

Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost GlobalCompliancePanel brings a new webinar on the topic of Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost. Webinar will be on April 6, 2010. Webinar will be presented by David Nettleton. This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software more...

From MentorHealth

The Top Five Issues for Health Information Security Compliance What to do About Encryption Mobile Devices Disaster Recovery Docu Even though every health care organization is different and has different problems and different needs, most organizations face similar sets of security risks that must be mitigated. In fact, information from the US Department of Health and Human Services based on breaches and audits shows that the top five issues they find are similar to the ones voiced by the chief information officers of health more...

From University of Kansas Continuing Education

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...

From Visualization Academy

NEW TRENDS IN TECHNICAL PUBLICATIONS

Course examines the newest trends in area of technical publications along with new technologies that allow you to leverage 3D engineering data directly to create superior content, faster! Learn to repurpose engineering files without recreating them so you can directly modify and change images to meet your specific needs, such as controlling resolution, that are difficult with screen captures. more...

From TrainHr

Bulletproof Documentation HR Supervisor Manager Training - Webinar By TrainHR In our litigious society, it has become more & more important for supervisors to know how to document & discipline employees to avoid law suits and manage employee performance effectively. more...

From Consepsys Information Management

Document Control Training A comprehensive and hands-on document control training course, covering all aspects of document control tasks. Specialized in Oil and Gas, Energy, Engineering Projects and Construction sectors. more...

From iGallant Solutions

Six Sigma Green Belt SSGB ...a Project tracking. Measure a Process analysis and documentation a Collecting and summarizing data. a Probability and statistics a MSA a Process capability. a SIPOC a Data conversions, a Sampling methods a Develop data collection plan a Process flow Metrics tables, WIP, takt time, cycle time, throughout. a Process analysis tools, VSM, Process maps, flow more...

From Clinical Solutions Medical Training

Assisting With Medication Certification Course ...n" (right medicine, patient, time, dose, route, form, and documentation) 6. Summarize the uses, contraindications, side effects and implications of common medication classifications. 7. Apply infection control principles to assisting with medications. Please visit our website at www. clinicalsolutionsme. com to sign up for this online class. Class includes study guide and test. If you more...

From ClickStart

Flare training

We offer in-depth, hand-on, online and onsite training for MadCap Flare for students worldwide. Classes include intro/ intermediate, advanced stylesheets, advanced single sourcing, and migrating from FrameMaker, Online classes use GoToMeeting or WebEx (both free) with local numbers available for 20+ countries. The class can be fully customized based on student interests and real-world more...

From InfoStar International

Peoplesoft Upgrade Specialist ...ribing Application Upgrade Process a Gathering Upgrade Documentation a Identifying Upgrade Planning Tasks a Describing the Software Install a Configuring Change Assistant for Upgrades a Creating an Environment a Creating an Upgrade Job Preparing the Database a Preparing Databases for Upgrade a Comparing Customizations a Describing a Database Compare a more...

From International Trade Center

Import Training Certification

International Trade Center: Importing 101 & More Importing Can Be Complex and Profitable! Learn How to Import From the Experts. Topics include: U. S. Customs and Border Protection Requirements, International Sourcing, Regulatory Compliance, Transportation, Documentation & Logistics, International Payment Procedures, Cultural Communications & Negotiations. Certification by ISM, upon completion of more...

From Keen Info Solution

Online Training for OracleApps technical R12 with 6y Real Time Expert ... Profile Option in Oracle Applications. AIM Documentation Preparation. MD 70, CV 60, TE20, MD 120 Reports 6i in Oracle Applications Introduction and Usage of USER_EXITS. Developing a Report from scratch as per Client Requirement. Developing a Report based on MD 50 Document (Reports in GL, AP, PO, INV). Multi-Org Concepts in Oracle more...

From Global BioPharmaceutical Resources, Inc. (GBPR, Inc.)

COTS Software Validation 10 Easy Steps This webinar describes efficient techniques for performing COTS validation. The 10-step risk-based approach to COTS software validation makes documentation more manageable and understandable. Learn how to increase productivity and minimize resources, usually saving two-thirds of the time and costs. Ensuring compliance of new and upgraded computer systems. Learn how to use risk management to more...

From MicroType

Improve Your FrameMaker Skills on-going series ... HTML outputs. Add interactivity and enhancements to your documentation by inserting hypertext markers for navigation, activation of external files and programs (including e-mail clients and web browsers) and more Mastering Running Headers/ Footers, November 5 (starting 11am PST) Techniques for smart retrieval of information from body pages into running headers/ footers. How to automate more...