Virtual Seminars

14 August 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 built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

15 August 2018

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.

16 August 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.

20 August 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 leading to

20 August 2018

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.

21 August 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.

27 August 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.

28 August 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. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyond.

29 August 2018

6-Hour Virtual Seminar - Complying With New FDA FSMA Preventive Control Rules: Planning Valid Preventive Food Safety Controls

The final rules for the Preventive Controls for Human and Animal Foods are now published. Large businesses have until September 2016 to fully implement the rules. Since validated preventive controls mean major changes to your company's way of operating, the time to begin planning and implementation was yesterday.

30 August 2018

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.

31 August 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.

5 September 2018

6-Hour Virtual Seminar on How to be HIPAA Compliant

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

10 September 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.

10 September 2018

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.

11 September 2018

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

17 September 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.

20 September 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.

20 September 2018

6-Hour Virtual Seminar - Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The final rules on the Sanitary Transportation of Human and Animal Foods establish training requirements for all carrier personnel engaged in food transportation operations.

21 September 2018

6-Hour Virtual Seminar on Risk Based Scientific Approach to Analytical Method Development and Validation Activities for Regulated Laboratories

This 6 hour virtual seminar introduces the schematics of Methods Development and Validation with a grassroots , conceptual standpoint based on scientific rationale and a Method by Design approach, a concept akin to QbD .

21 September 2018

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.

25 September 2018

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.

26 September 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.

28 September 2018

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.

1 October 2018

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.

1 October 2018

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!

10 October 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.

12 October 2018

6-Hour Virtual Seminar 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

16 October 2018

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.

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.

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