Events from ComplianceOnline | Environmental XPRT

Laboratory Inspection and Auditing

Sep. 23, 2020 Philadelphia, PA, USA

Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.

Validation, Verification and Transfer of Analytical Methods

Jun. 15-16, 2020 Amsterdam, Netherlands

Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, ...

Design for Safety

May 14-15, 2020 Detroit, MI, USA

Manufacturers of any product—from medical devices to automobiles—must create items that are, above all else, safe to use. Not only is this essential to long-term brand value and corporate success, but it’s also required by law. But while perfection is the goal, defects are bound to occur, especially in advanced products such as automobiles. When a safety defect does occur, auto manufacturers must initiate some form of recall ...

2-Day Virtual Seminar: Operations Risk - Active Management and Compliance

May 11-13, 2020 Virtual Seminar, CA, USA

This course provides a systematic approach covering the fundamentals needed to manage operational risks and operations risk management (ORM) compliance in banks and financial institutions. Based on the three-core approach to operational risk management, it expands into critical issues such as risk analysis, risk appetite, probability, impact, and risk mitigation processes.

Hazard Analysis and Risk Management under ISO 14971:2007/2012

Apr. 28, 2020 Online,

In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.

REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

Apr. 2-3, 2020 Tampa, FL, USA

This 2 day seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest on both directives and will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms. REACH and RoHS have been referred to as "…one of the most complex regulations in the ...

Risk Based Internal Auditing (RBIA)

Apr. 2-3, 2020 Sydney, Australia

The Institute of Internal Auditors defines Risk Based Internal Auditing (RBIA) as a methodology that links internal auditing to an organization’s overall risk management framework. RBIA allows internal audit to provide assurance to the board that risk management processes are managing risks effectively, in relation to the risk appetite.

Operations Risk Management and Mitigation - from assessment to implementation

Mar. 30-31, 2020 Sydney, Australia

This is an intensive course on Operational Risk Management & Mitigation – from assessing the operational risks to how to implementing a working, viable operational risk management program. Aimed at the financial services industry this course explores the Operational Risk management function and mitigation requirements as mandated in the Basel Accords.

Data Integrity: FDA/EU Requirements and Implementation

Mar. 26-27, 2020 San Diego, CA, USA

Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the world cite data integrity as a cause of observations and enforcement action, and actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity ...

Preparing for FDA`s New Import/Export Trauma in 2020

Mar. 19-20, 2020 Orlando, FL, USA

The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one ...

The Essentials of Managing Operational Risk

Mar. 18, 2020 Online,

This webinar provides a systematic approach covering the fundamental steps needed to manage operational risks in banks and financial institutions. Based on the three-core approach to operational risk management, it expands into critical issues such as risk analysis, risk appetite, probability, impact, and risk mitigation processes.

Implementing Operations Risk Management within an ERM Framework

Mar. 11, 2020 Online,

Sound management of operational risk is an integral part of strong governance, risk and compliance (GRC) and enterprise risk management. In this session, the instructor will define operational risk and explain how to identify, quantify, manage, and control it. He will discuss why all employees must be cognizant of these risks in their day to day jobs and how an organization can better manage and control these risks that have resulted in the ...

Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments

Mar. 10, 2020 Online,

This webinar will discuss how to use tiered approaches to evaluate the benefits and risks of novel nanomaterials and product formulations containing nanomaterials, as well as common risk mitigation approaches.

BSA/AML/OFAC Risk Assessments - Are You Doing Them Correctly

Feb. 27-28, 2020 Dallas, TX, USA

Although financial institutions have been managing BSA operations as per the regulatory requirements, the change in focus to appropriate BSA/AML/OFAC risk assessment has become increasingly important. Regulators look to the organization for insurance and evidence that BSA operations are appropriately performing risk assessments. Appropriate risk assessments are essential in an organization’s strategic planning and development, as well ...

FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

Feb. 27-28, 2020 San Francisco, CA, USA

It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be ...

HIPAA Privacy Rule Compliance-Understanding New Rule & Responsibilities of Privacy Officer

Feb. 26-27, 2020 San Francisco, CA, USA

While the HIPAA rules have been in place for years now, the focus of their application has recently changed as technologies and practices have changed, and changes to the rules are also on the horizon. In addition, there are changes in other regulations that interact with HIPAA requirements, and that require consideration in your planning. This session will focus on understanding what are the challenges that a HIPAA Privacy Officer faces ...

Reduce Costs for Compliance with Data Integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Feb. 26-27, 2020 Scottsdale, AZ, USA

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

Detecting and Preventing Internal and External Fraud

Feb. 21, 2020 Raleigh, NC, USA

Organizations of all kinds and sizes are increasingly threatened by fraud. Embezzlement, kickbacks, check fraud, financial statement fraud and vendor billing schemes are just a few of the countless economic crimes committed by employees and outsiders. This two day interactive in-person seminar will provide auditors and other financial professionals with a strong foundation of practical knowledge about how common frauds are committed using a ...

Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Feb. 20-21, 2020 Salt Lake City, UT, USA

A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in ...

Latest Changes to RoHS and REACH for 2020

Feb. 20, 2020 Online,

This 1-hour webinar will go into the specifics of the REACH and RoHS regulations and review the latest amendments and changes to both regulations for 2019. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.

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