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  • 1 Request Info

    Batch Record Review and Product Release 2018

    Overview: Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 2 Request Info

    Excel Spreadsheet Validation for FDA 21 CFR Part 11

    Overview: Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
  • 3 Request Info

    GDPR - European Privacy Regulation what and how

    Overview: The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls. Why should you Attend: Consequences of noncompliance are: High fines, up to 20 million Euro Lawsuits (Personally) liability cases Reputation loss
  • 4 Request Info

    How to Implement an Effective Human Error Investigation Program

    Overview: Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
  • 5 Request Info

    Webinar on ACH Death Notification Entries (DNEs) & Reclamations: Your Bank's Liability

    Get a detailed explanation on how federal government payments differ from the NACHA Operating Rules and ACH Death Notification Entries. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/ACH-Death-Notification-Entries-DNEs-Reclamations-Your-Bank-s-Liability-503000/AUGUST-2018-ES-TRAININGREGISTRY
  • 6 Request Info

    Webinar on On the Alert: Crafting an Effective Incident Response Plan (IRP)

    This webinar will advise users on how a well-designed, pressure-tested incident response plan can save your organization from significant financial, reputational, and regulatory issues. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/On-the-Alert-Crafting-an-Effective-Incident-Response-Plan-IRP-508195/AUGUST-2018-ES-TRAININGREGISTRY
  • 7 Request Info

    Webinar on Effective Records Management & Document Control for Medical Devices

    This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Effective-Records-Management-Document-Control-for-Medical-Devices-505756/AUGUST-2018-ES-TRAININGREGISTRY
  • 8 Request Info

    Webinar on AML for International Correspondent Banking

    Learn the basic of AML, Correspondent Banking, and the Wolfsberg Group and also address the risk issues related to AML compliance. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/AML-for-International-Correspondent-Banking-505216/AUGUST-2018-ES-TRAININGREGISTRY
  • 9 Request Info

    Regulatory Filing Requirements and Compliance Processes for Life Sciences

    Overview: This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.
  • 10 Request Info

    Webinar on AML - New Techniques for Laundering Money

    This webinar will discuss and reveal some of the new techniques for laundering money. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/AML-New-Techniques-for-Laundering-Money-502769/AUGUST-2018-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar on The FDA Inspection Process: From SOP to 483

    Discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/The-FDA-Inspection-Process-From-SOP-to-483-506420/AUGUST-2018-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar on Commercial Appraisal Review - Focus on the Tough Ones

    This webinar provides introductory information for banks and credit unions to work toward meeting the regulator's appraisal program requirements. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Commercial-Appraisal-Review-Focus-on-the-Tough-Ones-507165/AUGUST-2018-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar on Monitoring High Risk Transactions

    Learn BSA/AML compliance best practices to understand and assess your company's high risk financial transactions and activities. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Monitoring-High-Risk-Transactions-504508/AUGUST-2018-ES-TRAININGREGISTRY
  • 14 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.
  • 15 Request Info

    What You Need to Do to Prepare for a Successful Inspection

    Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs, and increase inspector confidence in the Quality System. Successfully completing an FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal.
  • 16 Request Info

    Controlling Human Error in the Manufacturing Floor (New 2018)

    Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.
  • 17 Request Info

    FDA continues to enforce through its new 21 CFR Part 11 inspection

    Overview: FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems. There are many questions about the program, e.g., what inspectors are looking at what are major findings.
  • 18 Request Info

    Quality Agreements Made Easy (Advanced 2018)

    Overview: The requirements for the assurance of quality within networks and circles of entities whose responsibilities are increasing specialized present an especially vexing challenge to the managements of each of these organizations. The specification developer must be aware of the capabilities of the contract manufacturer and the contract manufacturer must be aware of the limitations of the specification developer, for example.
  • 19 Request Info

    Compliance for Risk Based Approaches for (Clinical Trials 2018)

    FDA and EMA have communicated their expectations for trial oversight/ monitoring, monitoring systems, and investigative site oversight. These are described in the FDA Guidance Oversight of Clinical Investigations: A Risk- Based Approach to Monitoring and the EMA Reflection Paper on risk-based quality management in clinical trials both of which will be reviewed in this web seminar.
  • 20 Request Info

    Improving Compliance and your Company's Bottom Line (MedicalDevice Cybersecurity)

    Overview: This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats. Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient. There are many forms of cybersecurity and many remedies for thwarting attempts to penetrate medical device software. Most of these are based in physical and logical security practices that are becoming best industry practices. This webinar will detail some of the threats and ways to mitigate them to protect consumers from harm.