Audits Web-based Seminars

FLSA CLASSIFICATION MISTAKES - INDEPENDENT CONTRACTORS AND STUDENT INTERNS The Department of Labor has waged all out war on employers that misclassify their employees as independent contractors. This is a hot topic for the Department of Labor and employers that don't understand the law risk potential audits and lawsuits. Attend this informative in-depth webinar to learn how to properly identify who is an employee and who is an independent contractor. Get up-to-date on  more...

Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs. Wednesday, June 20, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, May 1, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

What to do if you get a FDA 483 Warning Letter - Webinar By GlobalCompliancePanel Overview: Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Thursday, March 29, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco ...verview: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide  more...

How to Survive a QRM Audit - Webinar By GlobalCompliancePanel Overview: As QRM tools and techniques become more formalized, regulatory agencies are increasingly requiring companies to establish Quality Risk Management Plans for their operations. Such plans are being used as starting points for regulatory audits.  more...

Management Styles that Work Best for Each of the Four Generations in the Workplace - Webinar By TrainHR This session is designed to help you manage more effectively by being able to differentiate between each generation and adapt to their style and outlook and capitalize on their strengths  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanel This webinar details both regulations and provides details for implementing computerized systems. Tuesday, December 6, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Advanced HR Audit Techniques - Webinar By TrainHR ...inar provides an update on the status and evolution of HR audits. The HR auditing process is or should be an independent, objective, and systematic evaluation that provides assurance that: 1) compliance and governance requirements are being met 2) business and talent management objectives are being achieved 3) human resource management risks are fully identified, assessed, and managed;  more...

Audits In The Health Care Industry - Getting Ready for an Outside Audit - Webinar By mentorhealth You need to attend in order to control your own destiny. Get involved up front instead of being a "sitting duck". Tuesday, October 11, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc ...audits and how they are approached will be discussed. The Internal Audit Lifecycle will be followed from beginning to end. It will be shown that. Internal audits are not simple exercises to determine compliance to some regulatory standards. Instead, the focus must be on auditing the company's quality system to determine if they are meeting their objectives and are effective in resolving quality  more...

Meeting Annual US FDA cGMP Training Requirements - Webinar By GlobalCompliancePanel 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. Wednesday, October 5, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted.  more...

Design Planning and Conducting Effective Audits - Webinars by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement.  more...

Design Planning and Conducting Effective Audits by gcp Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement.  more...

Validating Radiation Sterilization for Medical Device Industries by gcp ...eful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be incorporated into the design inputs correctly. Areas Covered in the Session: Introduction Terminology / Definitions Radiation characterization / effectiveness Process Equipment Product and Material Issues Process  more...

Assessing Unemployment Insurance Cost Controls by Train HR This webinar discusses the purposes and methodologies of UI audits in assessing an organization's unemployment insurance controls and the use of UI audits in reducing the organization's UI risk exposure and lowering UI tax liabilities and costs. Critical areas of UI cost management are reviewed and effective cost control strategies are identified.  more...

21 CFR Part 11 and Annex 11 What you Need to Know to Pass the New Regulatory Audits This webinar details both regulations and provides details for implementing computerized systems  more...

Advanced HR Audit Techniques by TrainHR This webinar provides an update on the status and evolution of HR audits.  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...le information request forms and questions asked at prior audits will be presented. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement. The HIPAA Privacy, Security,  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed. Why you should attend: Increasingly U. S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the  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...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel ...view and illustrate audit plans, system inventory, system audits, CAPA and remediation programs. Why should you attend: "Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or state regulatory inspector can send shivers down your spine. Are you ready for an internal QA or FDA inspection at your site? Areas Covered in the Session:  more...

How to successfully create a Device History Record and keep FDA happy in the process - Webinar By GlobalCompliancePanel ...and warning letters, seizures or worse ensue. Internal Audits show the production controls system compliant, yet again FDA writes the firm up. This webinar will review the production records regulations; with an emphasis on just what is it that FDA is looking for. Emphasis will be placed on the Quality System Inspection Technique (QSIT) which FDA uses as an inspection tool. Learning  more...

Best Practices for the Implementation and Use of Test Management Tools - Webinar By GlobalCompliancePanel ...lication, therefore all applicable SDLC documents, vendor audits, validation/ qualifications, operation/ support, training and general use of the Test Management Tool must be considered, prior to deciding if a Test Management Tool should be used to maintain the companies corporate validation policies. This presentation will provide details regarding Implementation, Configuration, Operations,  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. Monitoring systems should include specific components to ensure control of investigational  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...hich 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 some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing  more...

HIPAA Business Associates How the regulations have changed and what you need to do for compliance now - Webinar By GCPanel .... * BAs will learn how to be prepared for compliance audits and avoid the mandatory penalties for willful neglect of compliance. Areas Covered In the Seminar: * Learn about the new requirements for HIPAA Business Associates * Find out what has changed for Business Associates * Learn how the definition of BA has been significantly expanded * Learn what goes into a  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...ment your incidents and breaches to withstand enforcement audits. Areas Covered In the Seminar: * Learn about the HIPAA Breach Notification Rule * Find out what is a breach * What to do to prevent a Breach * What to do to prepare for a Breach * What to do when a Breach occurs * What you have to report, to whom ,and when * How to avoid Breach Notification  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ...effective way to increase the likelihood of your internal audits identifying issues that the inspector will see is to arrange your internal audit scheme to mimic the process the FDA inspector will use. If you perform your internal audits this way, you'll be well prepared for the FDA. Areas Covered In the Seminar: * History of FDA inspection methodologies, from haphazard to QSIT.  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ace or enhanced. Meeting the challenges of more "on site" audits. Getting supplier buy-in. Coping with "rogue" suppliers. Areas Covered in the Session: * Regulatory "Hot Buttons" * Classify suppliers; Supplier requirements by "classification" * What's behind the COA? The COC? * The FDA's increasing emphasis on the site audit * Types of remote audits *  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ... 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 recent public concern over  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...hat to expect and handle the difference between 'regular' audits and Part 11 audits o Some of the common audit findings and common pitfalls as well as tools for a successful planning and execution of the audit * Module 4 - Audit Trails o Types of audit trails o Strategies for implementing complaint audit trails o Pros and cons of audit trails  more...

Preparing for GFSI and other Third Party Audits - Webinar By GlobalCompliancePanel ...should attend: More and more customers are requiring GFSI audits such as ISO 22000, BRC and SQF or accepting them in lieu of their own audits. Without passing scores on these audits, companies are losing current accounts and are denied access to new accounts and business. Many organizations are new to the process of audits and associated standards. Thus, they are seeking out expensive  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ...kes an organization can make is to have insufficient self audits. Internal audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the confidence in the companya ™s ability to assess and improve its own  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...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 an auditor to determine  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...rograms. And the regulations include new requirements for audits by the US Department of Health and Human Services and mandatory penalties in the event of willful neglect of the regulations. This teleconference 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  more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel Overview: The purpose of auditing is to identify failures in the system or gross negligence. The real question, "how bad does the system need to be for auditing to work?" This talk will look at statistical distribution for rare events to show that the sample size needs to larger when the systems are better. This is a paradox for most auditors who when a problem is discovered increase their  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ...or shift in the emphasis of the U. S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements. In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/ RA and its senior management. There is "no business as usual". This change in focus has a major impact on interpretation of individual  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel ...d the tools to utilize during an audit is also discussed. Audits at best are snapshots of what exists at the moment of the audit; however, a good audit or auditor will be able to uncover the less obvious signals and signs of concern. Learn what to include in an audit, what to examine, where to look, to whom to speak, and what areas are the best indicators of problems. Being able to find  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...

Value-Adding Internal Auditing Learn how to get your Internal Audit System to promote improvements and add real value to your or Auditing is a critical function of a medical product company. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor's  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...

The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDD's TF/ DD. Differing purposes / goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and  more...

Design Planning and conducting Effective audits ...on the topic of Design, Planning and conducting Effective audits. Webinar will be on March 23, 2010. Webinar will be presented by Mark Roberts. Internal quality system audits should be viewed as an improvement tool. Too often due they have a negative connotation and are viewed as a necessary evil. Effective audits can comply with the regulations and also be a source of improvement. Proper  more...

The Top Five Issues for Health Information Security Compliance What to do About Encryption Mobile Devices Disaster Recovery Docu Even though every health care organization is different and has different problems and different needs, most organizations face similar sets of security risks that must be mitigated. In fact, information from the US Department of Health and Human Services based on breaches and audits shows that the top five issues they find are similar to the ones voiced by the chief information officers of health  more...