Validation Web-based Seminars

ITIL v3 Release Control and Validation Capability RCV ...le and processes associated with the Release, Control and Validation of services and service delivery. The main focus of this course is on the operational-level process activities and supporting methods and approaches to executing these processes in a practical, hands-on learning environment. This training is intended to enable the holders of the certificate to apply the practices during the  more...

Introduction to Spring Training This course enables the experienced Java developer to use the Spring application framework to manage objects in a lightweight " IoC " (inversion-of-control) container. Spring is a far-reaching framework that aims to facilitate all sorts of Java development, including every level of multi-tier distributed systems. Here we focus on the " Core " module of the framework, developing facility in  more...

Spring-MVC Web Applications ...l for any tier of any Java application. So is Spring ' s validation framework, and so we study these things in a mix of standalone (Java SE) applications and web applications. Then students build web applications that use the Spring MVC framework to rationalize their designs into coherent request/response cycles. They use Spring command objects to manage HTML forms and their data, and  more...

Apache Struts Training This advanced course shows JSP and servlet programmers how to build web applications using the Apache Struts framework. Students learn the Struts architecture and see how it captures a great deal of pre-existing best practice: in model/view/controller action mappings, form beans and custom tags for working with HTML forms, input validation, and the Tiles view-building framework. Two chapters  more...

Advanced ColdFusion Training: Components, Error Handling and Complex Objects In this advanced ColdFusion class, you will learn the many methods of reusing code (including , custom tags and stored procedures). You will also learn how to predict and prevent errors so your users will never see ugly error pages. In addition, you will learn to use Regular Expressions to perform advanced form validation.  more...

Medical Device Process Validation - Statistical Aspects - Webinar By GlobalCompliancePanel The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance". The presentation explores the statistical underpinnings of these two phrases. To "fully verify the output" relates to the use of statistical sampling plans, while "high degree of precision" relates  more...

Verification vs Validation in Regulated Industries - Webinar By GlobalCompliancePanel Overview: Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles. Thursday, March 1, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers ...Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the  more...

Computer System Validation Step-by-Step - Webinar GlobalCompliancePanel This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. Thursday, January 26, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Verification of Compendial Methods according to the New USP Chapter 1226 - Webinar By GlobalCompliancePanel This webinar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation. Thursday, January 12, 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...

Excel Spreadsheet Validation to Eliminate 483s - GlobalCompliancePanel 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. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Excel Spreadsheet Validation for FDA 21 CFR Part 11 - Webinar By GlobalCompliancePanel This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Tuesday,  more...

Master Verification Validation Planning under US FDA CGMP ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCom FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. Wednesday, March 21, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Risk Management in IEC 60601-1 Third Edition - Webinar By GlobalCompliancePanel IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be  more...

New Process Validation Life-Cycle Approach - Apply statistical tools to demonstrate Process Capability - Webinar By GlobalCompli This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Wednesday, December 14, 2011 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...

Excel Spreadsheet Validation to Eliminate 483s - Webinar GlobalCompliancePanel 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. Tuesday, January 10, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Working with the Pharmacopeias and Compendia - Webinar By GlobalCompliancePanel Every developed country has a pharmacopeia, including the European Union. This webinar will explore the function that the pharmacopeias play in the regulation and quality control of pharmaceutical products. The pharmacopeias play a key role in setting standards for individual pharmaceutical products. These standards are both for the physico-chemical properties of pharmaceuticals and for the  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar By GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Thursday, October 20, 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...

Introduction to Contamination Control Master Plans - By GlobalCompliancePanel Why you should attend: Manufacturers of human medical products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal fashion. Thus, each element in a manufacturer's control  more...

Designing an Effective Cleaning Validation in todays Regulatory Environment - Webinar By GlobalCompliancePanel This webinar concentrates on designing effective cleaning validation studies. Key benefits of this seminar include: Learn what steps should be followed. Identify critical parts of cleaning validation process. Achieve satisfactory inspections. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls.  more...

Excel Spreadsheet Validation to Eliminate 483 - Webinar By GlobalCompliancePanel 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 yo  more...

Establishing a Reduced Testing Program for Pharmaceutical Medical Device Components Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements.  more...

Master Validation Planning - Webinar By GlobalCompliancePanel A Validation Master Plan (VMP) is a critical part of a successful validation project. It documents the intended path to be taken for the validation of an entire organization, one or multiple plants, a single system or assembly line, or even a collection of similar equipment, to be qualified and eventually validated.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP ...validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, 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  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...

Verification vs Validation in Regulated Industries - webinars by gcp Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...ical 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 hour seminar you will obtain a basic understanding of the principles, core requirements of the ISO standard as well as related standards and guidance. We will define how radiation sterilization works, the equipment involved, major  more...

Statistical Concepts of Process Validation BY GCP The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".  more...

Lyophilization What you Need to Know Validation and Regulatory Approaches by gcp This course explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.  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...

Excel Spreadsheet Validation to Eliminate 483s by gcp 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.  more...

Introduction to Master Validation Plans - Webinar By GlobalCompliancePanel This webinar provides an introduction to the creation, implementation, and maintenance of Validation Master Plans. Key benefits of this seminar include: Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformances. Reduce rates of batch rework and rejections. Avoid product recalls. Take a holistic  more...

Water System Design Start-Up and Validation - Webinar By GlobalCompliancePanel This webinar provides a thorough examination of water systems. We will explore the typical components used in water systems and how these components are combined to achieve intended water quality specifications  more...

Analytical Test Methods Validation for GxP Laboratory Compliance FDA ICH and USP Requirements - Webinar By GlobalCompliancePanel This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method validation  more...

Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ...verview: This webinar will provide an overview of process validation for devices and pharmaceuticals. While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel ...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 acceptable software validations. The  more...

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

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...ased company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget,  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel verview: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems.  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...ggressively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited  more...

Webinar on Cloud Computing SaaS - Webinar By GlobalCompliancePanel ...ce (SaaS) Webinar will present the best practices for the validation of a SaaS Customer Relationship Management (CRM) Solution. Our presentation will offer an introduction to cloud computing and explain the benefits of using a SaaS system. We will detail the differences between a Conventional Implementation and a SaaS Implementation Methodology. A SaaS CRM system will be utilized as an  more...

Requirements of the Master Production Record - Webinar By GlobalCompliancePanel Overview: 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...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...nyone 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) during  more...

Gowning Systems Used in Cleanrooms Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables. Key benefits of this seminar include: * In-dept understanding of cleanroom garments and their use. * Reduce personnel-related environmental contamination issues. * Achieve satisfactory inspections more easily.  more...

Facilities Cleaning in Cleanrooms and Controlled Environments - Webinar By GlobalCompliancePanel Overview: This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies. It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are: * In-dept understanding of  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel Overview: The purpose of FMEA is to affect the design and the most practical time to do this is when competing designs are being considered, not after choices have been made, contracts signed, and prototypes being built and tested. Of course, there are other reasons for performing a FMEA. FDA requires risk assessment (hazard analysis) but a FMEA conducted late in the product development process  more...

Good Documentation Practices for GMP Operations - Webinar By 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. According to the FDA, if it isn't written  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...ng Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/ or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities. Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...ion of raw materials, third party (CMO) manufacturing, or validation lots. Why should you attend: The process for the disposition of product lots can be tedious and overwhelming. The requirements for intermediates, Active Pharmaceutical Ingredients (API), drug substances, medical devices, finished product, and even in-house manufactured components must meet certain specifications and/ or  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...ld 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 requirements, and it will have recommendations and provide tools for effective implementation. Reference material for  more...

Bringing Compliance To Design Control For Older Products - Webinar By GlobalCompliancePanel ... product release including: design change control, design validation, and the Design History File. The webinar is designed to help regulatory Affairs, Quality Engineers, and Design Engineers maintain released products within current regulatory requirements. As an attendee you will learn what the FDAs expectations for your released products are. You will also learn about the paper trail you  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. While technically"guidance," FDA has indicated they will enforce compliance rigorously. This complete overhaul of FDA's primary validation standard brings U. S. drug. API, and biologics process validation up to par with the advanced and  more...

Validating Rapid Microbiological Methods - Webinar By GlobalCompliancePanel ...validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms, such as rapid microbiological methods (RMMs). Because many RMM technologies  more...

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel ... 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. Areas Covered in the Session:  more...

Process Validation for Medical Devices - Webinar By GlobalCompliancePanel ...he knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program. The purpose of this course is to provide an introduction to the fundamentals of process validation, explaining how, when, where and why one  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote  more...

XML Training ...Validating against schema/ DTD. What can be testes with Validation What can not be tested with this. Comparing the XML with predefined XML What can be testes with this. What can not be tested with this. Testing the XML Schema Static Testing Reviewing the XML schema diagram Understanding the Schema Diagram Demo of reviewing the schema diagram Validating the XML  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel ...rect 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. Effective use of such risk management tools can help address the growing push by the public and  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...et produces the results you want. We explain the built in Validation tools and how to use them to prevent the user from entering incorrect data. We explain the use of Formula Auditing to help ensure the calculations are performed correctly. Lastly, we explain the use of Protection to prevent inadvertent and unauthorized changes. To satisfy the broadest interest, we use Excel 2003 to illustrate  more...

Introduction to Contamination Control Master Plans - Webinar by GlobalCompliancePanel Overview: This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: * Achieve satisfactory inspections more easily * Higher assurance of new medical product  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...

Process Validation current industry practices and FDA Guidance Document Review - Webinar by GlobalCompliancePanel ...Validation is 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  more...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel Overview: Although Part 11 has been around for over a decade, lack of visibility can sometimes render compliance with this regulation an afterthought. Due to serious inefficiencies and non-conformance issues associated with trying to address Part 11 late in the system lifecycle, it is important to give the technical requirements due consideration early in the process. A good understanding of  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ... Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ... down during implementation 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  more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...ially Unsafe Products * Recalls * Verification, Validation and Improvement of Food Safety Management Systems * Improvement * Automation of Management Systems for management of Food Safety. Who Will Benefit: * Presidents/ Vice Presidents/ CEOs * Top Managers * Quality, environmental, or health and safety managers interested in understanding requirements  more...

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

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...mpanies. The employees who will benefit include: * Validation managers and personnel * Engineers involved in water system design and installation * Utility operators and their managers involved in maintaining and sanitizing water systems * QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors  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...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...ay. The interaction of calibration, qualification, method validation and equipment maintenance on laboratory compliance and data quality will be discussed. Why should you attend: The analytical instruments and laboratory equipment are easy targets for inspectors looking to cite observations of non-compliance. Are yours ready for the internal QA and external regulatory inspectors? Areas  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...ction to Deviations & Quality Failures (0: 10) Module 9: Validation Module 10: Maintaining Label Control-From Design to Label Application Module 11: Storage and Distribution & Returned and Salvaged Products Module 12: Returned and Salvaged Products Module 13: Laboratory Controls Module 14: Problem Solving-Nonconforming, Investigations, and CAPA systems Who will benefit: *  more...

Excel Spreadsheets - Develop and Validate to Eliminate 483s - Webinar By GlobalCompliancePanel ...earn 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 user,  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...ions. * 15 Case Studies: Implementing Part 11 * Validation templates and examples Areas Covered In the Seminar: * FDA inspections: Preparation, conducts, follow up * Learning from past Part 11 inspections * Scope of the new Part 11 program: time frame, expected outcome * Criteria for selection of target companies * What inspectors are looking for *  more...

Key Concepts in Successful Water System Sanitization - Webinar By GlobalCompliancePanel Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization approach, as well as the frequency of the sanitization process have everything to do with its success. This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ... * Mandated Areas for Annual Reviews * The Master Validation Plan -- Corporate and Site(s) * Training Issues * CAPA * Trending * Facilities; Production and Process Controls * Suppliers, Contract Employees, Consultants * Some basic OSHA Concerns; ties to the cGMPs * Adverse Events Reporting Who Will Benefit: * Senior management in Drugs,  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...

Process Verification and Validation - by GlobalCompliancePanel ...efinement of their manufacturing process verification and validation programs. It will evaluate validation practices that are more in agreement with ICH Q7 and Q8 than previously accepted validation methods, and will provide thought-provoking questions for FDA-regulated companies. Enhanced use of existing FDA tools by a company will be discussed. What are the expected industry trends for  more...

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel Excel Applications are widely used in laboratories, offices and manufacturing e. g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for  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...

Using Statistics to Determine Sample Size - Webinar by GlobalCompliancePanel This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain  more...

Interfacing Design Verification Process Validation and Design Validation - Webinar by GlobalCompliancePanel There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements.  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

Transfer of Analytical Methods FDA Expectations and Tools for Implementation - Webinar by GlobalCompliancePanel ... 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 to execute meaningful Method Transfers of company methods by selecting appropriate analytical performance characteristics and  more...

21 CFR Part 11 - What you need to know to pass the new FDA audits - Webinar by GlobalCompliancePanel This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...essively pursue enforcement actions. This FDA Software Validation and Verification (V&V) training/ webinar will review the validation planning process with particular emphasis on avoiding most common pitfalls. Software V&V is an extremely important requirement for ensuring the safety and reliability of software used in manufacturing, devices, design, and quality systems. FDA has cited  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan ... targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). A matrix  more...

Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel ... The Global Harmonization Guidance document on process validation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process parameters and develop challenge points for the Operational Qualification (OQ) phase. The guidance explains the concepts of process capability showing the relationship between the  more...

Excel Spreadsheet Validation To Eliminate 483s - Webinar by GlobalCompliancePanel 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 will make  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel ...oted by the FDA for recalls of medical device is improper validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we  more...

Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 - Prepare Yourself for the upcoming FDA Part On July 8, 2010, 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  more...

Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel ... 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 reason and purpose of USP chapter and helps you to interpret what is required for verification of pharmacopeia methods to satisfy  more...

Ten-Step Process for COTS Computer System Validation - Reduce Time and Cost ...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 validation minimized documentation and  more...

Risk-Based Validation of cGMP Systems How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.  more...

21 CFR Part 11 - Compliance for Electronic Records and Signatures GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 24, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase,  more...

Process Validation for Drugs and Biologics ...pliancePanel brings a new webinar on the topic of Process Validation for Drugs and Biologics. Webinar will be on March 17, 2010. Webinar will be presented by James Harris. Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems GlobalCompliancePanel brings a new webinar on the topic of Internal 21CFR Part 11 Compliance Auditing of Computer Systems. Webinar will be on March 11, 2010. Webinar will be presented by Richard Poser. Mr. Poser is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device  more...

Excel Spreadsheet Validation To Eliminate 483s ...el brings a new webinar on the topic of Excel Spreadsheet Validation To Eliminate 483s. Webinar will be on March 10, 2010. Webinar will be presented by David Nettleton. Mr. Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase,  more...

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

Complete Java Training ...ntroller elements * Struts Tags * Tiles framework * Validation Framework * Struts Architecture o MVC and Model 2 o Command Pattern o Action Mappings o JavaBeans in Struts o Working with Forms o Validation o Tiles * Action Mappings o Command Pattern for Web Applications o ActionServlet o Action and ActionMapping o Struts Configuration o Struts Forward o Global  more...