Background Web-based Seminars

Introduction to Java Training ...s intended for students without an extensive programming background. It covers most Java syntax elements, concentrating on fundamental and universally useful elements, while providing an overview of many more advanced elements. Students will learn to write useful Java classes, applying Object-Oriented concepts such as inheritance, and create Java programs that work with these classes. The  more...

Advanced CSS Training This advanced CSS training class students will learn to use CSS to format forms, create list-based navigation, do advanced page layouts, and create stunning background effects. Students will also learn about CSS coding conventions and shorthand properties.  more...

Introduction to Visual Studio .NET Introduction to Visual Studio .NET provides you with a solid background on Microsoft ' s .NET technology so that you can decide whether it is appropriate for your next project and how it can integrate into an enterprise.  more...

The FDA Inspection Process From SOP to 483 - Webinar GlobalCompliancePanel Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? 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,  more...

Construct and Manage the Technical File and Design Dossier - Webinar 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...

RAPS Approved Seminar on The A to Zs of Microbial Control Monitoring and Validation of Pharmaceutical Water Systems ... water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often dona  more...

RAPS Approved Seminar on Microbial Control Monitoring and Validation of Pharmaceutical Water Systems at Mumbai ... water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often dona  more...

RAPS Approved Seminar on The A to Zs of Microbial Control Monitoring and Validation of Pharmaceutical Water Systems at Mumbai ... water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often dona  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...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...r your organization. This teleconference will provide the background and details necessary to develop an understanding of the origins of the HIPAA security regulation and the process used in complying with the rule, which leads, inevitably, to the adoption of policies and procedures. With the expansion of electronic devices and systems in use for health care, remote access and use of data  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ...background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example. The Information Security Risk Analysis Process presented utilizes a non-technical approach,  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ... Areas Covered in the Session: * The historical background of why the GCP standards were developed * The concept of and the purpose of a GCPa * The thirteen ICH Principles of a GCPa * The ICH definition of a GCPa and how it is applied * The Regulatory requirements to follow to be GCP compliant * Who, in the clinical research team is responsible that  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel ...s DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Why Should You Attend: Verification and validation requirements have always  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ... benefits including: o An understanding of the background of the Breach Notification Rule and what it calls for in the regulations. o Where to find the information and forms for filing breach notifications with HHS. o What goes into an effective breach notification policy? o How to prevent breaches as much as reasonably possible. o What  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...the Session: * Specific discussions include * Background of the original guidance, its history, application, and items covered * FDA regulatory authority * Growth of competing standards and the competing expectations of the medical device industry * The history and philosophy of the new guidance * The three stages of the new guidance, their sequence, and  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel Overview: Food, Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...rity Requirements Under HIPAA o The Regulatory Background of HIPAA o Overview of Security Requirements o Recent Changes to HIPAA Security Requirements o Structure of the HIPAA Security Regulation * The Security Rule Compliance Process o Concepts of Compliance with the Security Rule o Flexibility Provisions - one size does  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...ention Detailed Agenda: Introduction and Regulatory Background * There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. * Current trends with the 510(k) process. The Process * Who is Required to Submit a 510(k) * When a 510(k) is Not Required * When a 510(k) is Required * Locating and justifying the  more...

Construct and Manage the Technical File and Design Dossier - Webinar By GlobalCompliancePanel ...stomers have a prior CE Mark and Medical Device Directive background. The Technical File is a comprehensive collection of information and documents that details everything about your medical device. Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device, a less complex CE Marking Technical File may be required. In  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ... will benefit from this program/ webinar. It will provide background for OTC Drug labeling regulations and an understanding of how to comply with FDA requirements. Potential FDA enforcement actions regarding OTC drug labeling will also be covered. Areas Covered in the Session: * OTC Drug Labeling regulations: background and requirements * Drug Facts labeling * OTC Monographs  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA  more...

Master Verification and Validation Planning to Meet US FDA ISO 13485 and 149712009 Requirements - Webinar by GlobalCompliancePan FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or 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  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ...tickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis of these requirements, the presentation examines available guidance documents. The FDA issued the Medical Device Quality Systems Manual  more...

Business Broker Training Webinar ...line classroom setting. He can cater the training to your background, experience level and geographic area. This is like having your own personal online business broker trainer. The training can be done during the day or in the evening. THE BEST PART - after deposit - you can break your training fee into installments spread out over the year. NO installments until February 1, 2011. Your  more...