Compliance Training Webinars for Regulated Industries

The consequences of an immune response to biologicals, range from transient appearance of antibodies without any clinical significance to severe life-threatening conditions. Understanding why an immune response is generated, how to detect or predict its generation will help in designing products that will be efficacious and therapeutic.

Attend this webinar to understand the DHS temporary flexibility in the requirements for completing Form I-9, Employment Eligibility Verification, while employers are operating remotely. Learn how Employers can mitigate the changes and still stay compliant.

In response to the global coronavirus pandemic, the UK’s MHRA has published guidance designed to protect the drug supply chain. The scope of the guidance is far-reaching (see below for details) and includes temporary changes to GMP and GDP expectations as well as some licensing arrangements.

This training program will discuss a new employee’s role in his/her orientation and difference between orientation to the organization and orientation to the department. The program will also explain gap analysis, force field analysis, and SWOT analysis in assessing your organization’s onboarding requirements.

This program examines what is currently known about the coronavirus disease 2019 (COVID-19). COVID-19 is a respiratory illness that can spread from person to person. The outbreak first started in China, but the virus continues to spread internationally and in the United States. This webinar provides information from the CDC, the World Health Organization and OSHA which may help prevent workplace exposures to COVID-19, in non-healthcare settings. This program also provides planning considerations for home and community spread of COVID-19.

This webinar will focus on the proper steps for employers to take and employees to follow once the green light to return to work post-COVID is given. You will learn what experts say and what regulatory agencies require as we transition back to work.

This session will focus on conducting a risk/benefit analysis of both the positive and potential negative impact of the advancement of AI and ML devices in the medical device industry. It will provide a further understanding of the FDA's current thinking on the implementation of regulatory policies to ensure safe and effective medical devices that advance the quality of life of the patient. Artificial intelligence technology is rapidly spreading across the medical field, as systems are being developed that can identify signs of illness and disease in a wide variety of imaging situations such as MRI and CT. AI devices are complex with respect to algorithm used in their development, information being input in to the systems in which they learn, and the recommended out from such learning.

Although there are no official regs for cosmetic GMP’s, failure to maintain control of your operation can lead to severe regulatory consequences. You can avoid unwanted FDA oversight by maintaining cosmetic processes under control. One avoidable recall could result in a domino effect having tremendous negative impact on your organization.

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.