6-Hour Virtual Seminar on Combination Products

Gives real life examples of how to register and maintain various types of combination products.

This seminar provides Professionals working in this area with:

  • A thorough understanding of the complexities involved
  • Covers all the relevant regulations and guidelines
  • Gives real life examples of how to register and maintain various types of combination products
  • Interfaces: Change Management and LCM
  • Compliant safety reporting for combination products
  • Documentation requirements and interfacing

6-Hour Virtual Seminar on Transition from Peer to Supervisor

This seminar will equip newly promoted supervisor with tools and techniques.

Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees.

Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.

6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

In this course you will learn the keys to writing effective SOPs.

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance.

For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

6-Hour Virtual Seminar – HIPAA – Emailing, Texting, and Personal Devices

This six-hour seminar will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission.

This six-hour seminar will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission.

I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.

6-Hour Virtual Seminar – Batch Record Review and Product Release

A strong batch record review system is essential in order to properly document all critical processing parameters.

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.

6-Hour Virtual Seminar on A Risk Based Approach To Data Integrity

This course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system.

This course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system

Why you should attend

This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.

This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems

6-Hour Virtual Seminar on Moving From An Operational Manager to A Strategic Leader

Gain the insights and skills to know where your business stands today and where it’s heading tomorrow.

Gain the insights and skills to know where your business stands today and where it's heading tomorrow.

In today's unpredictable business environment, strategic leadership is not just for top management alone. It's for:

Managers who want to increase their competitive advantage by anticipating their customers' priorities, needs and expectations

Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs' flexibility and responsiveness

Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department's value to the organization

Every manager who wants to anticipate, initiate and manage change for maximum competitiveness!

6-Hour Virtual Seminar on HR Compliance 101 – for Non HR Managers

Knowing what to do in employee situations can be difficult for even seasoned Managers and Supervisors, especially if a Supervisor has never had training.

Knowing what to do in employee situations can be difficult for even seasoned Managers and Supervisors, especially if a Supervisor has never had training. For a new Supervisor these problems are intensified. Employee problems easily morph into compliance and legal challenges and often with lighting speed while the Managers and Supervisor is still trying to get a handle on problematic situations. Many have never been trained in even the rudimentary basics of employment law and therefore do not even recognize problem situations until it’s too late.

Nevertheless, by the time an employee problem reaches HR, a level of liability has often been created. How an employer handles such problems, can either limit or increase liability. Further exacerbating the problem is that Supervisors often inherit a dysfunctional department and/or are promoted to supervise those with whom they once were coworkers.

6-Hour Virtual Seminar on HIPAA Training for Compliance Officer

Addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur.

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.

The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA – I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.

6-Hour Virtual Seminar on Effective Technical Writing in the Life Sciences

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

This seminar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this seminar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.