Compliance Training Webinars for Regulated Industries

The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read a Monograph, whether or not a certain ingredient can be used, the parts of a proper label, and a variety of other important requirements needed to be successful.

Applying Six Sigma techniques to laboratory practices increases efficiency, decreases waste and improves morale. This presentation will demonstrate how applying DOWNTIME can help improve the efficiency of lab service and function.

This webinar provides some practical and useful answers to the question: “What Strategies Should I Use to Speed Up Formulation Development?” A strategy based on QbD principles that have been proven to effectively and efficiently develop useful multi-component formulations is presented in this webinar. A critical goal is the creation of formulation understanding and design space that will consistently produce a product that meets specifications with minimal risk of failure. This strategy will be described and discussed along with several examples of its use.

Attend this webinar to learn how to recognize bias in your workplaces and take the necessary steps to reduce and address bias.

This course for pharmaceutical professionals provides the information they require, to prepare for and understand what will happen during a mock audit and during a Pre-Approval Inspection (PAI).

This webinar will explain the structure and timeline of a customs audit, and teach attendees how to successfully prepare for an audit. Attendees will learn the best practices for trade compliance and customs compliance that you can implement while importing/exporting to minimize penalties. Also you will learn how to establish a reasonable care process, identify the characteristic of internal controls along-with real life examples of implementing a compliance program successfully.

This training on trade compliance will help the attendees understand the rules to qualify your imports/exports between United States, Mexico, and Canada. You will also learn best practices on how to complete the NAFTA certificate of origin to avoid penalties.

The challenge for HIPAA privacy and security, cyber security and information security professionals is not alleviated with the OCR’s relaxed standards, during COVID-19. Hackers are using the COVID-19 crisis to steal information, at an alarming rate. Providers are now serving their patients at home, which have weakened security measures in place. Patients and providers information is now at risk as hackers target through telehealth portals.

This webinar will discuss handling situations where training has been identified as a root cause during an investigation. Rather than prescribing the all too common, and largely ineffective, re-training event, discover quick and powerful ways to get at what influenced the individual, and how to address these underlying factors to more effectively prevent recurrence.

COVID-19 is not your typical Human Resources Force Majeure! Human Resources Managers are faced with unique risks related to local, State, and Federal, and international regulations and requirements. HR cannot afford to fail to analyze and plan to mitigate risks systematically. Even more problematic is dealing with unexpected risks such as the coronavirus. Learn to create mitigation plans for anticipated risks and a plan to deal with the unexpected. Use some simple tools to analyze risks and prioritize the need for planning. Be confident as you avoid unnecessary "firefighting" and manage risk strategically.

This webinar pulls together current US FDA and UK MHRA guidance covering medical devices and diagnostic tests during the current COVID-19 emergency. Particular emphasis will be given to ventilators and other respiratory aids within the medical device topic.

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar will help you create an inspection readiness plan so you are well prepared for an FDA inspection. This webinar can help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

Virtual work exponentially increased in the current health crisis as well as constantly grew in the last few years as more and more organizations have people working from virtual and remote locations. They need leadership, management and communication just as it was needed conventionally when we all went to an office environment together. You need to learn how to lead, manage and create connection with your team members and clients. In this new virtual environment, you need to differentiate yourself from all the newcomers and novices that have been forced to try it without much training or experience. We will review the top 7 steps you need to take to become a great virtual manager and leader.

Attend this webinar to learn how to translate a new guidance or regulation into a working process, and how to use process flow, techniques and templates to develop procedures on your own. The webinar will provide you with a working SOP for Risk Management.

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide pharmacovigilance and quality assurance departments with an overview of regulatory requirements and expectations for Good Pharmacovigilance Practice audit programmes, with a focus on auditing of activities internal to an organisation as well as those contracted out to service providers and commercial partners, such as distributors and licence partners.

The current coronavirus pandemic has created problems for the management of ongoing clinical trials. In response, regulators have produced guidance aimed at protecting the safety of subjects and clinical trial integrity. This webinar sets out how the US FDA and UK MHRA expect those involved in the management of clinical trials to address these problems.

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments. There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done.

COVID-19 has been a fast-growing, communicable and deadly disease that became a world-wide pandemic. With this disease attacking the US population it changed our lives, and even more specifically, hospital operations. As hospital operations changed, our hospital case management roles and processes changed, as well. As this deadly virus seems to be leveling off, there will be a time that we return to normal. However, our "old" normal will probably not be our "new" normal.

Have you considered the significant negative impact that unsafe behavior can cause in your organization? The impact goes well beyond the pain and suffering of the injured employee, the workers’ compensation cost and the impact of organizational reputation. Could an unsafe behavior act be an OSHA Act violation under the General Duty Clause?

DOL has implemented the Overtime Regulations effective January 1, 2020. Attend this webinar to learn how the new rules impact employers. It will also identify resources and tools that can be used to reduce risk and focus on growing businesses.