22 October 2018

6-Hour Virtual Seminar on Practical Strategies for Teaching Self-Regulation, Social Skills, and Instructional Consequences to Adolescents with Autism Spectrum Disorders

As more and more students are being identified with Autism Spectrum Disorder, educators, parents and therapists are looking for the best practices to help these students experience success in the school and home setting as well as supports for communication, social skills and behavior.

23 October 2018

6-Hour Virtual Seminar - Evolution of the Quality Management System - How to go from Surviving to Thriving

This 6 -hour virtual seminar will help you to develop a Quality Management System (QMS) for Medical Device Companies.

24 October 2018

6-Hour Virtual Seminar on Establishing Quality of Pharmaceuticals: Concepts, Practices, Regulatory Compliance Requirements - Challenges and Solutions

The focus of the seminar is to provide a concise overview of the scientific basis of quality assessment and requirements of meeting regulatory compliance requirements. Current challenges facing the industry in this regard will be highlighted, with suggestions to address them, will be described in detail.

25 October 2018

6-Hour Virtual Seminar on Effective Complaint Handling and Medical Device Reporting

Complaint Handling and Medical Device Reporting (MDR) are a part series on Post Market Compliance

25 October 2018

6-Hour Virtual Seminar on Controlling Human Error in the Manufacturing Floor

Human error is known to be the primary cause of quality and production losses in many industries.

26 October 2018

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability

26 October 2018

6-Hour Virtual Seminar on Medical Device Recalls: How to Properly, Compliantly and Promptly Deal with a Recall

The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical

29 October 2018

6-Hour Virtual Seminar on Statistical Process Control & Process Capability

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified.

30 October 2018

6 Hour Virtual Seminar - HIPAA 2018 - Staying Competitive and Complying with HIPAA

This webinar will begin by discussing and emphasizing the importance of truthfulness to the process

31 October 2018

6-Hour Virtual Seminar on HIPAA - Emailing, Texting, and Personal Devices (Myths vs Realities)

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

1 November 2018

6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

1 November 2018

6-Hour Virtual Seminar on Developing a Clinically or Bio- Relevant Drug Dissolution Method and Establishing Plasma Drug Profiles

Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule.

5 November 2018

6-Hour Virtual Seminar - The New EU Medical Device Regulation

In 2012, the Commission adopted a package of measures on innovation in health.

5 November 2018

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

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

7 November 2018
7 November 2018

6-Hour Virtual Seminar on HIPAA Security - 2018 and Beyond

This six-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more.

8 November 2018

6-Hour Virtual Seminar on eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product

9 November 2018

6-Hour Virtual Seminar on Integrative Resilience Solutions for Better Work - Life Balance: Managing Stress & Thriving in the Modern Era

Integrative Resilience Theory is a new and highly effective platform from which to build, change and grow

12 November 2018

6-Hour Virtual Seminar on Master Class for the HIPAA Officer: Protecting Patient Information and Implementing Today's Privacy, Security, and Breach Regulations

The session begins with overview of the HIPAA regulations and then continues with presentation of the specifics

13 November 2018

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

16 November 2018

6 Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process

16 November 2018

6-Hour Virtual Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems

This course is appropriate for beginner and experienced person alike.

29 November 2018

6-Hour Virtual Seminar - Medical Claims Boot Camp - Cracking the Code to Healthcare Billing, Coding and Reimbursement

This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the goal of helping those who work with medical claims and claims data stay ahead of the game.

29 November 2018

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.

30 November 2018
30 November 2018

6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

3 December 2018
4 December 2018

6-Hour Virtual Seminar on Statistics for the Non-Statistician

The world is swimming in data yet raw data is mostly useless without methods to turn this data

7 December 2018

6-Hour Virtual Seminar on Private Practice Essentials - Tools for Starting and Developing Practice

This day long webinar aims to train practitioners who already own a private practice are just getting started

7 December 2018

6-Hour Virtual Seminar on Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties

The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc.

10 December 2018

6-Hour Virtual Seminar on HIPAA Audit Failure Wakeup Call - Lessons Learned - Steps for Success

There is a national crisis in HIPAA compliance, shown by the Phase 2 HIPAA Compliance Audit

11 December 2018

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

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.

11 December 2018

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

11 December 2018

6-Hour Virtual Seminar on A Process Approach to Quality Management Systems

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.

13 December 2018

6-Hour Virtual Seminar on Phase I GMPs

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

11 January 2019

6-Hour Virtual Seminar on GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

GxP/GMP regulations are required to be used in regulated industries such as food, pharmaceutical, medical devices, and cosmetics. GMP regulations describe required quality management system for production and testing of products in these regulated industries.

6-Hour Virtual Seminar on Statistics for Process Control

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Statistics for Quality Control

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

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

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.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2018

Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-hour Virtual Seminar on Controlling Human Error in the Manufacturing Floor

Human error is known to be the primary cause of quality and production losses in many industries.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on HIPAA 2018-Staying Competitive and Complying with HIPAA

This seminar will demonstrate how Covered Entities and Business Associates can comply calmly, confidently and completely with the HIPAA Rules.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on HIPAA Compliance - Clear, Complete, Step-by-Step

This seminar will demonstrate how Covered Entities and Business Associates can comply calmly, confidently and completely with the HIPAA Rules.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on HIPAA Security - 2018 and Beyond

This six-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyond.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on How to be HIPAA Compliant

This 6-hour webinar takes the participants through HIPAA compliance from start to compliance.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar - HIPAA - Emailing, Texting, and Personal Devices (myths vs realities)

This six-hour seminar will be going into great detail regarding you practice or business information technology and how it relates to

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems

This course is appropriate for beginner and experienced person alike.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Living with Depression - Unveiled

Mental illness is something that can take a dramatic toll on a person and all those around him.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Leadership and Team Development for Managerial Success

Inspire and influence your team members to achieve your goals as a team!

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

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

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on HIPAA vs. SAMHSA 42 CFR Part 2

This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on HIPAA Training for Compliance Officer

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Statistics for Process Control

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

6-Hour Virtual Seminar on Statistics for the Non-Statistician

The world is swimming in data yet raw data is mostly useless without methods to turn this data into useful

  • View Anytime
  • Duration: 6 Hours
  • Price: ¤595.00
  • View Details

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