A Good Understanding Web-based Seminars

Java EE Seminar for Managers This course provides a coherent, high-level explanation of the Java Platform, Enterprise Edition (Java EE): what sorts of software are created with Java EE; how software is developed for this platform; how it is deployed and put into production; how it can be administered. The course is designed specifically for non-programmers -- analysts, managers, technical writers, and anyone who desires a  more...

Auditing Computer Systems for FDA and International Compliance - Webinar By GlobalCompliancePanel This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation. Tuesday, March 13, 2012 10: 00 AM PST | 01: 00 PM EST  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...

How to Prepare for Manage and Follow-up to an FDA Inspection - Webinar By GlobalCompliancePanel The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!  more...

Business Analyst Competency Development Program BUSINESS ANALYST Competency Development Program About Zarantech: Zaran Tech is a global IT training and consulting services company with one goal in mind a develop and deliver the highest quality consultants to our Clients and customer. As a consulting company, we help organizations to work smarter and grow faster. We consult with our clients to build effective organizations, innovate & grow,  more...

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

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

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

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

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

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel Overview: If you handle any electronic patient information, dona ™t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation. Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing. API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification  more...

Conducting Successful Product Complaint Investigations - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations. An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel Overview: This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and  more...

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans -- Webinar By GlobalCompliancePanel Overview: This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how  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...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel Overview: ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W Overview: As a quality professional, you desire to have the very best quality system that operates effectively, efficiently and conforms to the appropriate quality standards to meet customer and user needs. You are also aware that there is a paradigm shift from an emphasis on compliance to an emphasis on quality based systems. An understanding of this paradigm shift can be gained by comparing  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel Overview: This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion  more...

Validation of ExistingLegacy Computer Systems for FDAEU Compliance - Webinar By GlobalCompliancePanel ...ut 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 easy implementation: * SOP: Retrospective Validation of Computerized Systems * Checklist: Retrospective Validation of Computer Systems Areas Covered in the Session:  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel Overview: The new HIPAA Breach Notification Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not  more...

Off-Label Promotion of Medical Devices Maximizing Your Performance Claims within FDAs Framework of Acceptable Practices - Webina Overview: The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA. You will improve your understanding of regulatory expectations for your products and improve promotional compliance for released products. The webinar is designed to  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel Overview: This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel Overview: Virtually all field inspections performed by FDA inspectors are done according to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes straightforward, helpful methods for incorporating it into your companya  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl Overview: Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U. S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. FDA issued a 28-page Proposed  more...

Medical Device Recalls How to Manage Them and Recent Trends - Webinar By GlobalCompliancePanel Overview: Medical devices are classified into three classes, Class I, II, and III, based on the level of control necessary to assure the safety and effectiveness of the device. Recalls of Class II devices represent 61% of all device recalls over a review period, followed by Class III devices at 28%. This Webinar will provide a recent update on the latest trends and causes for device recalls and  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel Overview: This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running clinical trials. It will ensure you gain a clear understanding of the tools and techniques of project management for clinical trial and how they can be applied to your own pharmaceutical projects in the work place. In addition to key project management tools  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel Overview: This webinar helps you understand the FDA device regulations related to Excel spreadsheets. These spreadsheets can be automated processes and create electronic records. Both of these aspects are regulated by the FDA, so device manufacturers must understand the regulations and how to apply them. The seminar begins with Excel methods to help ensure the spreadsheet produces the results  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...

Understanding the Technical Requirements of 21 CFR Part 11 - Webinar by GlobalCompliancePanel ...ical requirements due consideration early in the process. A good understanding of these technical requirements is paramount to avoiding the syndrome of "testing into compliance" later on. Often, the compliance status of a system can be impacted by varying interpretations of the regulation if not properly addressed. This session will provide a focus on understanding the key considerations for  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team 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  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the Pharma - it is a good regulation for medical and Pharma companies but it is also a good guideline for other industries. Why Should You Attend: FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection.  more...

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

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel Overview: This presentation will assist organizations within the food chain to understand the requirements to meet the international standard for Food Safety Management. Areas Covered in the Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management *  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel Overview: This 3 hour Webinar is a primer and overview to the premarket notification process, i. e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may  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...

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...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the  more...

The Advantages of Linking Management Systems - Webinar by GlobalCompliancePanel Overview: It's important to improve the dialogue between financial, quality, IT and environmental management systems. Members of these management systems need to understand what the others do. Quality and environmental managers need to understand the language of finance and the effect of operations on the bottom line, while financial managers need to know how quality, environmental and IT  more...

Audit Committee Responsibilities for Internal Controls - Webinar By GlobalCompliancePanel Overview: With the advent of the Sarbanes-Oxley Act, audit committees are under increased scrutiny for helping management set the tone at the top and ensuring internal controls are documented and tested. As a matter of fact, the Audit Committee has the PRIMARY responsibility for oversight of internal controls. One thing audit committee member should expect is to have a clear understanding of  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...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel Overview: The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar.  more...

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

Understanding Attribute Acceptance Sampling including Z14 and c0 Plans - Webinar by GlobalCompliancePanel This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plana ™s performance using the operating characteristic (OC) curve. Participants will gain a solid understanding of how the OC curve is built, how to use it, and how to  more...

Project Management for the Phase 3 LCM Life Cycle Management of the Drug Development Process - Webinar by GlobalCompliancePanel This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running phase 3 clinical trials.  more...

Understanding Analytical Test Results Comparing Two Sets of Data - Webinar by GlobalCompliancePanel The class will cover the understanding the properties of single test results and how they may be compared. There are many problems that arise from a misunderstanding of the properties of single data sets and the problems are compounded when data sets are compared. The discussion will cover the misconceptions and present methods to allow proper comparisons, while considering the risks inherent  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..."  more...

Revamping the 510k Clearance Process-Understanding FDAs Proposals - Webinar by GlobalCompliancePanel The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical  more...

Robust Process Validation for Medical Devices - Webinar by GlobalCompliancePanel One of the most common reasons noted 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  more...