Auditing Web-based Seminars

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...

How to Survive a DEA Inspection Series For a Research Facility - Webinar By mentorhealth The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods. Thursday, December 1, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Advanced HR Audit Techniques - Webinar By TrainHR ...pdate 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; and 4) the  more...

Effective Internal Auditing-Making Quality Systems More Efficient for the Medical Products Industry - Webinar By GlobalComplianc The different types of internal 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  more...

How to Survive a DEA Inspection Series For Analytical Labs and Researchers - Webinar By GlobalCompliancePanel The training will cover DEA record-keeping and effective security that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.  more...

How to Survive a DEA Inspection Series Only Manufacturers and Distributors - Webinar By GlobalCompliancePanel This training will cover DEA record-keeping and security requirements that a registrant must comply with when handling controlled substances and regulated chemicals. It covers elements of what occurs during unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. As a firm handling those products, you will get a better understanding of what is  more...

Document Retention and Destruction ...ance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in compliance. Effective Human Resource Departments should have a documented Plan to manage employee records safely and  more...

Auditing and Administrating Human Resources Policies and Practices by TrainHR This webinar will concentrate on making sure you have current human resources policies that are in compliance with applicable laws and convey the desired practices in your organization. Policy should be reviewed and updated periodically and through this webinar you can review your current policies, clarify policies for easier administration, and perhaps add new policies others to address new  more...

Document Retention and Destruction by TrainHR You should attend this webinar to be sure both you and your staff in charge of records understands the responsibility and importance of knowing and following proper procedures. When auditing how information is kept by Human Resource Departments, many questions come up regarding where records are kept, how long they should be kept and when and how they should be destroyed in order to stay in  more...

Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors - Webinar By GlobalCompliancePanel This webinar will demonstrate how to implement an effective audit program. Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the firm's responsibility to make sure vendors/ suppliers are meeting specifications for the supplied  more...

HIPAA Enforcement and Compliance Audits What the auditors want and how to be ready before they call - Webinar By GlobalComplianc ...en in the past, but that's now changing - the HHS will be auditing HIPAA covered entities and business associates even if there have been no complaints or problems reported. * Find out what HHS OCR is likely to ask you if you are selected for an audit, and what you'll have to have prepared already when they do. * Find out what the rules are that you need to comply with and what  more...

Vendor Qualification Auditing for FDA Computer System Compliance - Webinar By GlobalCompliancePanel This Vendor Qualification training will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...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 processes  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems - Webinar By GlobalCompliancePanel verview: This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. This presentation will describe a proven process for preparing a site for inspection of systems.  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...ed in the Session: * What doe the FDA look at when Auditing/ Inspecting a study? * The Sponsor's responsibility in monitoring study conduct * Components of a sponsor monitoring system beyond SOPs * The nature of adequate oversight of all staff and non-staff * The importance of Protocol knowledge in preventing errors * How do sites prepare for an audit /  more...

How to use QSIT to Your Advantage - Webinar By GlobalCompliancePanel ... * Knowing how to utilize the QSIT approach in internal auditing. Who will benefit: During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is of high importance. This Webinar provides such an understanding. It will also benefit: * Top  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...ir vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners". Why you should attend: The last few years have seen the U. S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual".  more...

Excel Spreadsheets and FDA Device Regulations - Webinar by GlobalCompliancePanel ...om entering incorrect data. We explain the use of Formula Auditing to help ensure the calculations are performed correctly. Lastly, we explain the use of Protection to prevent inadvertent and unauthorized changes. To satisfy the broadest interest, we use Excel 2003 to illustrate the tools. The seminar shifts to the regulations for automated processes, found in 21 CFR 820. 70(i), and explains  more...

Effective Corrective and Preventive Actions CAPA 10 Steps to Success - GlobalCompliancePanel Virtual Seminar - Webinar By Global ...ess. Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you with enough ideas, suggestions and HOW TOs that you and your teams and organization overall get much better on the  more...

21 CFR Part 11 Complete Manual For Compliance Success - GlobalCompliancePanel Virtual Seminar - Webinar By GlobalCompliancePanel ...d certainly we have challenges with internal and external auditing for Part 11 compliance. This webinar will address all these topics and provides you with plenty HOW TO we as auditors and inspectors increase our comfort level with the regulation, with its elements and compliance and practically implement audit system and audit trails - especially since Audit Trails play major role in Part  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...e new, increased penalties for HIPAA violations and a new auditing process is being developed so that HIPAA covered entities will be subject to reviews by the US Department of Health and Human Services' Office for Civil Rights even if no one files a complaint. If you haven't done whata ™s required under the HIPAA Security Rule, you could be liable for willful neglect penalties that begin  more...

Assessing GCP Compliance in Clinical Trial Audits- Risk management and Best practices - Webinar By GlobalCompliancepanel ...linical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs). Areas Covered In the Seminar: * Discuss how QA differs from QC and who is responsible for each * Determine who gets audited and factors and metrics for assessing  more...

Statistical Sampling Plans for Audits - Webinar By GlobalCompliancePanel ...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 sample size. Most  more...

The Process Approach to Auditing - Webinar By GlobalCompliancepanel ... requirements laid out in Clause 4. 1, the foundation for auditing a process-based system, are taken up for discussion at this webinar. There are eight basic processes that an organization must have to function effectively. These are: * Management of the Quality System * Top management involvement * Customer focus * The improvement process * Design and development  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel ... visiting a firm and checking off a list of questions. Auditing API producers and suppliers is an important part of GMP compliance programs. Identifying what approach or process to use is examined and 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  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...

How to Survive a DEA Audit or FINDFINE - Webinar by GlobalCompliancePanel ...rs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel conducts an unannounced inspection of a pharmacy to perform an audit, they generally do not inform the DEA registrant on what steps will be taken during the inspection. In some cases, the pharmacist is not aware of what  more...

Auditing a Process-based System - Compliance Training Seminar by GlobalCompliancePanel There are a number of reasons for someone to attend this webinar. First and foremost they will gain an understanding of the process approach. The process approach requires management to identify all processes of the QMS, their sequence and interaction. They must ensure the effectiveness of all processes and the availability of needed resources, and monitor, measure, analyze and improve them. They  more...

How to Survive a DEA Audit - Compliance Webinar by GlobalCompliancePanel This training entitled "How to Survive a DEA Audit" will cover all the record-keeping and security requirements that a DEA registrant 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. As a firm handling these  more...

Design Planning and conducting Effective audits GlobalCompliancePanel brings a new webinar 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  more...

21 CFR Part 11 Auditing for Part 11 Compliance GlobalCompliancePanel brings a new webinar for the medical devices industry professionals. Webinar will be on March 18, 2010. Webinar will be presented by Jasmin NUHIC. 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.  more...

Internal 21CFR Part 11 Compliance Auditing of Computer Systems ...webinar on the topic of Internal 21CFR Part 11 Compliance Auditing of Computer Systems. Webinar will be on March 11, 2010. Webinar will be presented by Richard Poser. Mr. Poser is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the  more...

Process Instrumentation and Control Online Certificate Course The online certificate program in Process Instrumentation and Control (I&C) consists of three modules covering the different phases of I&C from a nonmathematical and practical point of view. It includes basic concepts, engineering, and installation of control equipment. The attendees will learn about: 1. Basics of I&C, including different control functions, types of control loops, and  more...