Responsibilities Web-based Seminars

Understanding The Violent Mind In The Workplace ...y. The potential for workplace violence creates unique responsibilities for leaders. It continues to be a topic of concern among management.. As figures indicate, more than 2 million workers annually are victims of some kind of violent attack. Although statistics vary, it is estimated that as much as 30 percent of these problems are caused by current or former employees. The source of the  more...

Clinical Research Associate ( CRA ) and Clinical Research Coordinator ( CRC ) Online Training Program The content of the Clinical Research Associate and Coordinator Training Program covers the Good Clinical Practice (GCP), the FDA and Health Canada regulations, the ICH Guidelines and gives numerous checklists and tips how to meet the job responsibilities. The course provides all the necessary information needed to be a successful Clinical Research Associate or Clinical Research Coordinator. The  more...

Personalized Online Clinical Research Training for Clinical Research Professionals The content of the Online Training Program covers the Good Clinical Practice (GCP), the FDA and Health Canada regulations, the ICH Guidelines and gives numerous checklists and tips how to meet the job responsibilities. The course provides all the necessary information needed to be a successful Clinical Research Professional. The course can be personalized so that it fits your requests.  more...

Top Tips For Managers to Prevent Harassment in your Workplace ... best protection is for managers to understand what their responsibilities are and learn tips to help them prevent harassment in the workplace. This interactive, informative sexual harassment prevention training, "Top 10 Tips for Preventing Harassment in Your Workplace," will provide the tips that managers should not be without. It includes a definition of sexual harassment and discussions  more...

Introduction to Microsoft Access 2003 Training ... Access 2003 database program to perform their day-to-day responsibilities, and to understand the advantages that using a relational database program can bring to their business processes. The introductory Access course is for the individual whose job responsibilities include working with tables to create and maintain records, locate records, and produce reports based on the information in the  more...

Advanced Microsoft Access 2003 Training ...Access training course is designed for students whose job responsibilities include working with heavily related tables; creating advanced queries, forms, and reports; writing macros to automate common tasks; and performing general database maintenance. It is also designed as one in a series of courses for students pursuing the Microsoft Office Specialist Certification for Microsoft Office  more...

Project Management Training ...ocioeconomic and organizational structure issues, and the responsibilities of a project manager. Course activities also cover defining the project scope, writing a project charter, developing a work breakdown structure, identifying time management components, describing schedule development, using mathematical analysis techniques, and assigning resources. Students will also learn how to  more...

MOC 6234 - Implementing and Maintaining Microsoft SQL Server 2008 Analysis Services This SSAS training class teaches students how to implement an Analysis Services solution in an organization. The class discusses how to use the Analysis Services development tools to create an Analysis Services database and an OLAP cube, and how to use the Analysis Services management and administrative tools to manage an Analysis Services solution.This SSAS class targets people who design and  more...

New Final HIPAA Amendments New final rules for HIPAA Expand the Scope and Increase Responsibilities This Webinar will help health information professionals understand what they have to do, and when, and what to keep in mind as they move forward, in order to be prepared for compliance with the new regulations. It will provide a comprehensive look at the changes in the law and prepare attendees for the process of incorporating the changes into how they do business in their facilities. Areas  more...

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

ITIL v3 Service Operation Virtual Instructor Led This five-day Live Instructor-Led online course provides you with an intense and focused exploration of the new and updated topics in ITIL ® v3 from the point of view of the owner of a process or set of activities. The course is intended for those who work within a Service Operation (SO) environment and require a deeper understanding of the underlying concepts, processes/ functions and  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP The verification and 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  more...

FDA Inspections - Dos Donts - webinars by gcp The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

FDA Inspections - Dos Donts The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues that often arise, such as confidentiality, fitness for duty evaluations, when and why to drug test, the relationship between conduct problems and mental illness, and how to directly address mental health problems with managers and  more...

CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Pharmaceutical and Medical Device Validation Guidances - Similarities and Differences - Webinar By GlobalCompliancePanel ... its role in maintaining product quality * Roles and responsibilities in the validation process * The process validation lifecycle from design to product discontinuation * How about Process Analytical Technology (PAT) * Similarities and Differences-Product and Process Design * Similarities and Differences-Equipment and Facilities * Similarities and  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...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel Overview: Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: 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 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  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...

The Pharmaceutical Quality System - Webinar By GlobalCompliancePanel ...orary quality standards, reference life cycle, management responsibilities, knowledge management, risk management, quality by design and many other concepts. Individuals in pharmaceutical firms, from the highest executive to the middle manager are wondering how these will fit into their organization and its Quality system, and how they will impact them, personally. This webinar will help the  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel ...ssociate rules have changed in fundamental ways, with new responsibilities and obligations for HIPAA BAs. The session will provide attendees the following tools, benefits, and solutions: * The audience will learn how business associates are now handled under the law and the proposed regulations and what has changed from the old rules. * The suggested and required content for a  more...

Developing the Risk Management Plan - Webinar By GlobalCompliancePanel ...tures, the Risk Management Plan must document the divided responsibilities and activities. The plan must cover all phases of the product lifecycle risk management activities. This presentation will discuss how to accomplish risk management planning in divided management structures. Why you should attend: One of the major requirements of the medical device risk management standard ISO 14971  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel Overview: This program is intended for those personnel who are concerned with the analysis and correction of problems (deviations and failures). This course provides clarity to the regulatory expectations and guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel ...o investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be: * Principal Investigators and sub investigators * Clinical Research Scientists (PKs, Biostatisticians, ...) * Safety Nurses * Clinical Research  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ... 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 identified by a review of recent Warning Letters. The  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations 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  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...mples and definitions of teams and team members roles and responsibilities o It can be used and applied in other areas inside and/ or outside the organization when and where team work is required and expected o This section by itself can be taken out and applied to other processes and practices within or outside of the organization with the goal of continuous improvement  more...

Reprocessing REUSABLE Medical Devices-Cleaning Labeling Requirements - Webinar By GlobalCompliancePanel ...edical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be resterilized by the user facility, cleaning & sterilization instructions must be precise and  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...acist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize themselves with the stringent laws and regulations enforced by the Drug Enforcement Administration (DEA) through their Office of Diversion Control (Diversion). Since the focus of any  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... if FDA requires additional information and data and your responsibilities Interactive Q&A, Wrap-Up and Adjourn * Q&A with all attendees * Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry * Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ... end? * Identify what information to report and your responsibilities * Understand the impact with user facilities and patient issues Who Will Benefit: This webinar will provide an overview and guidance to device manufacturers involved in medical device tracking activities. Employees who will benefit include: * All levels of management and departmental representatives and  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ...anged o License Terms o Maintenance Responsibilities * Comparing and Contrasting Japana ™s Procedures vs. U. S. FDA o Comparison of Processes o Agency Interactions o Accepted Practices * How and When to Influence the Regulatory Process o Japanese Way of Thinking / Coming to Agreement o Important Cultural  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...