Training And Assessment Web-based Seminars

DISC Training Webinar DISC TRAINING | Friday, February 24, 2012 | 1: 00 PM a 3: 00 PM CST Led by Paula Fracasso Discover your own behavior and how to relate best with each behavior style. Go beyond the interview and learn to accurately use the DISC Assessment tool when hiring. Learn to effectively coach your employees and/ or understand how to best train and manage an employee. **Tuition is $99 (includes cost  more...

How to Factually Evaluate Critical Supplier Performance and Risks Manufacturers and distributors are choosing to source significant amounts of materials and components from global suppliers and are creating substantial risks within their supply chains. Companies are discovering that sourced-material disruptions can and often do, result in dramatic and unfavorable impacts to material delivery reliability, total material cost and received material quality.  more...

LeaderNation Web-Based Certification The LeaderNation training certification course is for coaches, consultants, and HR professionals who would like to learn about 360 feedback and leadership competency modeling as a leadership development tool for individuals and organizations. The course is conducted over two weeks in five 1. 5 hour modules that cover the essentials of 360 feedback, including leadership competency modeling,  more...

Early Intervention Field Trauma Training First responders (e. g., fire/ rescue, emergency medical services, law enforcement) as well as mental health and health care professionals will benefit from Field Trauma training. This is an entry-level program and no pre-requisites are required to receive the Field Trauma designation other than successful course completion. Participants will learn about on-site responding and learn how to respond  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...

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

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...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel Overview: Laboratory equipment should be calibrated and/ or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of  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 Overview: When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems. This web seminar will give a good understanding on the regulatory  more...

Preparing for Pre-approval Inspections - Webinar By GlobalCompliancePanel Overview: This interactive webinar begins with an overview of the FDA Inspection process. Preparation for the inspection in the months before, the immediate weeks before and on the day of the inspection will be discussed. The Inspection process will be reviewed followed by a detailed look at common focus area areas of Inspectors. Procedures to be followed after the inspection such as  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel Overview: This interactive webinar will review the regulatory requirements for an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. Common pitfalls and means of overcoming them at each of the steps will be  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel Overview: This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you  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...

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...

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...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel Overview: This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how do design an effective training program, who is responsible for training, training effectives and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel Overview: A comprehensive review of an ideal chemical control program will be presented. The guidelines presented will enable your company to implement programs that are cost effective and meet or exceed the expectations of major QSR, and GFSI audit criteria. This presentation will provide not only a provide schematic for management and control of chemicals, but an interactive and customizable  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel Overview: In this NDA Approval Process training Webinar learn the guidance and regulations governing FDAa ™s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such  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...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel Overview: In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Why you should attend: Quality assurance is defined as a "systematic and independent examination of trial-related activities and documents" that allows  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel Overview: The FDA generally defines combination products as a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles  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...

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...

Recalls Removals and Market Corrections in Compliance with FDA and ISO Requirements - Webinar By GlobalCompliancePanel Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. 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 industry and what it (the FDA and industry)  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...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel Training is required in a number of areas of the HIPAA regulations and their policy implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to  more...

Training Requirements and Practices to Assure QSR and ISO Compliance - Webinar by GlobalCompliancePanel To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and  more...

How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement. Unfortunately, food supply chain members have lived outside of the quality world and have not invested the time, training or money to learn and apply the disciplines needed to bring quality into preventive levels of control. Visual inspection in many  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...

BRC Risk Analysis - Webinar by GlobalCompliancePanel Risk Assessment is a fundamental and intuitive activity that is not new to manufacturing professionals. Bringing consciousness and tangibility to this process is the challenge often faced. A practical guide documenting the process will be the topic of this training. This presentation will take you step by step through the creation of each type of risk assessment required by the BRC. Process and  more...

The ICF Process Tips on Achieving Optimal compliance and Comprehension - Webinar by GlobalCompliancePanel The ICF process, which involves communication between a consentee (patient/ subject) and a consenter (staff clinician/ designee), is a vital component to the authorization of any medical intervention or clinical research trial. IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear  more...

The HITECH Acts Impact on HIPPA - Webinar by GlobalCompliancePanel The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data  more...

Developing an Effective Supplier and Internal Auditing System - Webinar by GlobalCompliancePanel The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company's personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit  more...

How to Survive a DEA Audit or FINDFINE - Webinar by GlobalCompliancePanel This training entitled "How to Survive a DEA Audi or FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why  more...

Adobe eLearning Suite Lodestone Digital provides public Adobe eLearning Suite classes across the country that are certified by Adobe. In addition to our public classes, we can provide Adobe eLearning Suite training at your location for students who need custom solutions. Our instructors have years of Adobe eLearning Suite production experience, and specialize in implementing digital media tools into a workflow.  more...

Improving Communication This course shows participants how to read other people and to see how others interpret their behaviors. It leaves them with a gut-level appreciation for the needs of their co-workers. Ultimately, the course helps participants adapt their communication styles in a way that creates an enduring working alliance among those you communicate with. This program is designed to help participants:  more...