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  • Upcoming Webinars
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  • Live

    FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

    March 05 2021 1:00 pm Kenneth Christie
    A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice and address similar issues in advance. This ensures we will be better prepared for an FDA […]
    ATTEND
  • Live

    4-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

    March 09 2021 11:00 am Carolyn Troiano
    Electronic record/electronic signature (ER/ES) capabilities are extremely important and should be built into FDA-regulated computer systems to meets compliance with 21 CFR Part 11. This webinar will help you to strategize the development of a company philosophy and approach, as well as how to incorporate it into the overall computer system validation program for individual […]
    ATTEND
  • Live

    Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance

    March 09 2021 1:00 pm David Nettleton
    This interactive webinar by industry expert – David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a […]
    ATTEND
  • Live

    Is it Microbiological Method Verification or Validation, or Just Semantics?

    March 10 2021 12:00 pm Michael Brodsky
    Method validation and method verification are related terms. Unfortunately, the terms are often incorrectly used interchangeably. They have immensely different analytical and statistical requirements; particularly for compliance with ISO/IEC 17025:2005. This results in confusion and the application of inappropriate or inadequate analytical evaluations. Microbiology laboratory accreditation will need you to understand the differences between and […]
    ATTEND
  • Live

    Blockchain Innovations that Connect and Protect the Supply Chain

    March 10 2021 1:00 pm John E. Lincoln
    This training program will discuss the new blockchain innovations particularly as they can be used to connect and protect the regulated supply chain. The focus will be on how this can enhance cMGP compliance while it strengthens a company’s critical supply chain. This webinar will explore the growing use of blockchain in supply chain control. […]
    ATTEND
  • Live

    US vs EU – Medical Devices Compliance and Regulatory Affairs

    March 16 2021 1:00 pm Charles Paul
    This webinar will provide an understanding of the structure of both US and EU regulatory bodies. The regulatory content common to all regulations will be addressed to create a foundation for understanding the basics of medical device compliance regulations. We will then discuss the meaning of regulatory compliance from both an internal – company, and […]
    ATTEND
  • Live

    Current Regulatory Requirements for Aseptically Produced Products

    March 17 2021 1:00 pm Kenneth Christie
    The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents that address other issues such as closure integrity and sterility test methods that were recently revised. […]
    ATTEND
  • Live

    Pharmacokinetics (PK) / Pharmacodynamics (PD) Studies in Drug Discovery and Development

    March 17 2021 1:00 pm Dr. Stefano Persiani
    Pharmacokinetics (PK) describes the time course of drugs in the organism i.e. the processes that a drug undergoes after administration. PK, therefore, assesses the absorption, distribution, metabolism, and excretion of new chemical entities. In other words, what the body does to the drug. PK/PD is essential in drug discovery for target validation, optimization of lead […]
    ATTEND
  • Live

    3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations

    March 18 2021 11:00 am Danielle DeLucy
    This seminar will review the regulatory requirements for investigating 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. The structure of an Investigation report […]
    ATTEND
  • Live

    Supplier Quality Management Simplified

    March 18 2021 1:00 pm Jose Mora
    Changes in technologies and supply-chain arrangements have coincided with the expansion of regulations and standards to the entire supply chain. Unfortunately, many suppliers have not kept up or find themselves in a strange new world. It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations […]
    ATTEND
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  • Recording

    3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019

    John E. Lincoln
    Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while...
    ATTEND
  • Recording

    Effective Genotoxic Impurities Assessment In Drug Development

    Dr. Stefano Persiani
    Residual impurities resulting from the synthetic route, the formulation, or from the degradation of the active drug and/or the excipients, may be present in the pharmaceutical products that will be administered to patients. Some of these impurities may present...
    ATTEND
  • Recording

    How Will FDA’s New Approach to CSV Make Implementations Easier?

    Carolyn Troiano
    There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) could be in place before January 2021. Its focus is taking the principles...
    ATTEND
  • Recording

    Remote Auditing for Medical Device Companies

    Susanne Manz
    Internal Audit and Supplier Audits are essential for medical device companies to self-identify and mitigate risks. The COVID-19 pandemic has made this important task even more difficult due to travel restrictions. This webinar will provide insights into how to...
    ATTEND
  • Recording

    Examining and Implementation of ISO 13485:2016 Medical Device Quality Management System

    John E. Lincoln
    This webinar will examine the basic elements of the EU’s QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical...
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions

    William Levinson
    This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities....
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Design Controls for Medical Devices

    Susanne Manz
    Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers....
    ATTEND
  • Recording

    CSV Virtual Bootcamp Registration

    Carolyn Troiano
    ATTEND
  • Recording

    Training in Human Error: Reducing Training Related Errors

    Dr. Ginette Collazo
    We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program. Why You Should Attend Training programs have evolved through time. Human reliability or human error...
    ATTEND
  • Recording

    Virtual Site Audits for FDA Regulated Industries

    John E. Lincoln
    How can this little used internal inspection tool — “virtual” site cGMP-compliance audits — be used to assist in FDA regulatory compliance, and in meeting requirements for cGMP system audits / inspections of vendors, other remote located sites. Each...
    ATTEND
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  • Recording

    3-Hour Virtual Seminar on Medical Device Risk Management – Implementing ISO 14971:2019

    John E. Lincoln
    Hazard Analysis / Risk Management is a required in device development, validation, CAPA investigations / resolutions, and most other cGMP considerations. Both the U.S. FDA and the EU’s MDD/MDR require companies to be proactive in reducing product risk while...
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Statistical Process Control (SPC), Process Capability, and Non-Normal Distributions

    William Levinson
    This 3-session seminar will cover: Process capability and process performance, which reflect the ability of a process to meet specifications. A Six Sigma process will, when centered on the nominal, have only two nonconformances or defects per billion opportunities....
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Design Controls for Medical Devices

    Susanne Manz
    Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers....
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Project Management for Computer Systems Validation

    Angela Bazigos
    Project Management is defined as the planning and organization of an organization’s resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are...
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Off Label Promotion for Drugs and Medical Devices

    Angela Bazigos
    FDA and industry have struggled for the past 10 years, with the question of how FDA can reconcile its mission to protect public health by ensuring that medical products distributed in the United States are safe and effective for...
    ATTEND
  • Recording

    4-Hour Virtual Seminar on Design Control Program with Detailed Hazard Analysis, Human Factors and Software Discussions

    Edwin Waldbusser
    US FDA believes that a device cannot be considered safe and effective unless the design has followed a rigorously controlled step by step process. This virtual seminar will teach you how to set up and maintain a process that...
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Controlling Human Error in Manufacturing Floor

    Dr. Ginette Collazo
    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...
    ATTEND
  • Recording

    3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11

    Angela Bazigos
    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...
    ATTEND
  • Recording

    4-Hour Virtual Seminar on Preparing and Submitting Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications, and Conducting FDA Meetings

    Marina Malikova
    A key role is played by what you submit to the regulatory agency, they hold more than just written applications. They also enclose systematic tracking, editing, publishing and strategy of crucial data. Through precise instructions, case studies and first...
    ATTEND
  • Recording

    3-Hour Virtual Seminar on IQ, OQ, PQ in the Verification and Validation Process

    Susanne Manz
    Validation is an essential element of the Quality System Regulations and ISO 13485. This course dwells into the processes that need to be validated and what steps are needed to validate the processes. You’ll also learn the essentials of...
    ATTEND
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Refund Policy

Webinar Compliance reserves the right to cancel or reschedule any Webinar/event due to inevitable reasons such as insufficient registrations or circumstances beyond its control. All the attendees will be notified about the cancellation of the event, 24 hours prior to the start time of the Webinar event.

The cancelled Webinar, could be rescheduled and a New Date would be promptly intimated to the attendees.

In such an event, the attendee can opt for one of the below :

  1. If the New Date is not of convenience, the webinar stream (1-Time Recording) may be availed.
  2. The attendees may also opt to take a different webinar, which has a same price tag at a future date & time; they are welcome to do so.
  3. On-Demand recordings (Past events) in exchange but equal to the original amount remitted.
  4. A redeemable voucher (Valid for 12 months), which could be used to purchase any of our future events.
  5. Webinar Compliance will process refund only if an event that has been cancelled, is not rescheduled within 90 days from the original scheduled date of the webinar.
  6. If a webinar is canceled completely, an attendee may opt either of above points 2,3,4, or a full refund of the amount paid in a single settlement. The payment will be processed within 7 Business days from the day, we receive the refund request. However, Webinar Compliance will not be responsible for any penalties or other expenditure incurred due to the cancellation.

​Individual attendees can cancel their event for any specific reason. They must notify Webinar Compliance about the cancellation of their registration at least 48 hours prior to the event start date and time. In such an event, a refund will be processed, minus an administrative fee of $45, to the individual.

If the attendee fails to cancel the registration to the event within the above mentioned stipulated time or if fails to attend the event, no refund shall be made.

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​For further clarification on the refund or cancellation policy, you can contact the support team over the phone or please write to us on support@webinarcompliance.com, with the transaction ID, event ID & event date in the subject column.

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