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  • 1 Request Info

    Webinar on Medical Device Single Audit Program (MDSAP) - All You Need To Know

    What is MDSAP and where is it going? Will it eventually touch my business anywhere in the world? MDSAP is creating a playing field among regulatory bodies around the world. That playing field consists of the 6 critical regulatory bodies that are participating in the development of future considerations for an equivalent and reciprocal set of conscript elements of compliance to GMP conditions of operation. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 2 Request Info

    Does the Boss Really Have Horns?

    Overview: Managers are usually promoted to their role because of their technical skills and not their people skills. In fact, studies have shown almost a decade gap between when people get promoted and when people begin to seek out leadership skills. If you can understand where your boss is in the process, you may be able to help them become the boss you want them to be.
  • 3 Request Info

    Driving a Quality-Lean Steering Committee

    Overview: This session demonstrates how to develop, manage, and implement an effective quality Lean Management System (QLMS) steering committee. Attendees will observe the development of the key components of a steering committee. Several successful examples across various business types will be shared. Attendees will walk away with a model that they can apply to their own organizations.
  • 4 Request Info

    Failure Modes and Effects Analysis

    Overview: Failure Mode and Effects Analysis (FMEA) is a powerful tool for product quality. It has its roots in reliability but has expanded into other areas including process control. The primary purpose is to investigate failures and the way (the mode) they happen. This leads to an evaluation of the failure's effect on the product or process and measures to manage it.
  • 5 Request Info

    Networking for Fun and Profit

    Overview: Most people lack the basic networking skills necessary to do their jobs properly.These networking skills help us in many areas of our jobs. To begin, networking skills actually improve interpersonal communication skills with coworkers and supervisors. At the core, networking skills are about how to help people get to know you, like you, and trust you. These skills help ensure that every interaction you have with people leaves them happy that they interacted with you.
  • 6 Request Info

    Best Practices for Foundational Employee Success

    Overview: The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges.
  • 7 Request Info

    Quality Audit According to Gxp-GMP Requirements

    Overview: GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries. The purpose of the GMP regulations is to ensure that a product is safe and meets its intended use.
  • 8 Request Info

    Statistical Sampling Plans - Methods and Applications

    Acceptance sampling plans are important tools for manufacturers. Effectively used they can help reduce costs while assuring quality and controlling risks. Unfortunately, this rich field of techniques is not as prominent as it once had been. As a result, quality practitioners don't always appreciate the wide range of available options or understand how to choose among alternate statistical sampling plans. Click to Continue Reading:
  • 9 Request Info

    Managing Your FDA Inspection: Before, During and After

    FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. Click to Continue Reading:
  • 10 Request Info

    Tougher Import Rules for FDA Imports in 2018

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Click to Continue Reading:
  • 11 Request Info

    Complete 1099, TIN Matching, B-Notice, 1042-S Non-resident Alien and FATCA Compliance Update

    For years the IRS has struggled with the independent contractor, the non-resident alien worker, US citizens with foreign financial accounts and tax collection. They have placed the burden on businesses, non-profits and not-for-profits as well as state and local government to report information about taxable payments they make to their account holders, vendors and customers. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding information reporting on taxpayers by payers - the 1099 and the 1042-S. These time consuming reporting obligations can be streamlined in a number of ways. Click to Continue Reading:
  • 12 Request Info

    Evolution of the Quality Management System - How to go from Surviving to Thriving

    Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS. And an inefficient QMS results in wasted time, money, and missed opportunities. In this 2-day seminar, we will use lecture, exercises, and discuss to learn the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.
  • 13 Request Info

    HIPAA Training for the Compliance Officer 2018

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. Click to Continue Reading:
  • 14 Request Info

    European Data Protection Regulation - 2018 Implementation

    Overview: An overview of the history of Data Protection within the EU and introduce you to the enhancements and new obligations imposed by the EU GDPR. Why should you Attend: Attendees will learn the common EU rules that have been established to ensure that personal data has a high standard of protection across the EU. Attendees will also learn about their rights to complain and obtain redress if their data is misused in any of the EU member states.
  • 15 Request Info

    Eliminating Microbial Contamination in a Spiral Freezer

    Overview: It is able to enhance sanitation programs as it is able to penetrate the niches and crevices that were previously too hard to reach. By eliminating the ability for pathogens to "hide," chlorine dioxide gas is able to leave food processing environments cleaner and safer than ever before. Why should you Attend: Food production facilities are facing greater scrutiny from both the public and the government to provide safe foods. There are about 48 million cases of foodborne illness annually.
  • 16 Request Info

    HIPAA Compliance Requirements | HIPAA Privacy Security 2018

    Being the HIPAA Security and Privacy Official involves not only ensuring you know the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a breach investigation, you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. Read More:
  • 17 Request Info

    FDA Guidelines for Pharmaceutical Industry | FDA Regulatory 2018

    The FDA is increasing its enforcement actions both for domestic and foreign inspections. Enforcement statistics have not been summarized yet because 2017 has not ended yet. We are certainly seeing more Warning Letters and Import Alerts based on Data Integrity (21 CFR Part 11: Electronic Records; Electronic Signatures. In the past FDA used to issue several Warning Letters to the same firms upon consecutive inspections. Today, after receiving one Warning Letter the next regulatory action is elevated to Import Alert, Consent Decree, and Injunctions for domestic manufacturers. Read More:
  • 18 Request Info

    ISO 14971 Risk Management Training-IEC 62304 Risk Management

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. Read More:
  • 19 Request Info

    IT Infrastructure Qualification Plan | Information Technology 2018

    GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance. Effective IT Infrastructure Qualification on the other hand, confers the following benefits. Read More:
  • 20 Request Info

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Read More: