All Blog Posts (1,642)

This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers.

Learn how to prevent quality and compliance problems by having a strong system for supplier audit and management! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for managing your suppliers.



You'll learn about the essential elements of…

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.

Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.

Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And…

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential…

The US business environment as well as those of other countries have experienced over the years significant risk events with significant negative risk consequences. In recent times there have been a plethora of risk episodes in the corporate world.

Many of these episodes could have been avoided or modified if the entities…

How the Fair Debt Collection Practices Act Works.

The FDCPA does not protect debtors from those who are attempting to collect a personal debt. If you owe money to the local hardware store, for example, and the owner of the store calls you to collect that debt, he is not a debt collector under the terms of this act. FDCPA only applies to…

Communicating and enforcing dress code policies are essential. Learning to set and manage policies by working directly with internal managers, business partners and executives in handling issues such as inappropriate or provocative dress, unhygienic employees is important, as well as identify and mitigating any legal issues.(protected class…

A leader does not necessarily manage, but a manager had better be a good leader.

Why is leadership so important?

Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.

People don't leave companies, they leave bosses. Leadership is the most…

A leader does not necessarily manage, but a manager had better be a good leader.

Why is leadership so important?

Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.

People don't leave companies, they leave bosses. Leadership is the most…

A leader does not necessarily manage, but a manager had better be a good leader.

Why is leadership so important?

Without leadership, nothing gets done. Leadership brings the vision and ideas, and sets the course or direction. Managers ensure execution.

People don't leave companies, they leave bosses. Leadership is the most…

Students will have a good understanding of everything involved in setting up a maintenance plan for their property. They will be able to catch the "little" things before they become a costly emergency. In addition, they will be able to create an accurate, working budget which will maximize productivity and minimize…

This webinar covers the complete context of payroll rules and administration made simple. It starts with the basic classification of workers properly classified as Contractors or Workers.  Rules for Payment and administration of Contractors is outlined. Rules for workers   classified as "Exempt"  or "Non-exempt" based on FLSA .

Rules for payments to…

Do you say "yes" at work when you would rather say "no?" Are you concerned with what others will think of you? In this essential webinar, you'll learn how effective you are at boundary-setting and why it can be hard for good people to say "no."

You'll find out how poor boundary-setting can lead to feeling fed up, overworked and…

We'll begin by showing you how and why you should begin every presentation with an outline. The outline then becomes the framework of the presentation itself. Then we cover how to create and apply Microsoft Themes to get the precise look and feel that represents your organization's identity.

You'll see how to take your current company…

Being able to create and edit a macro is one of the must have skills for Excel Power Users. Having this knowledge will save you hours of time by allowing you to automate any Excel-based task or process.

If you've never created macros or used Excel VBA before, this webinar is for you.

The advanced excel training will be delivered using Excel 2016…

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.

Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in project management, and avoidance of non-compliance penalties.

• History and Overview
• Subpart A: General Provisions
• Subpart B: Electronic…

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.

This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.



This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to…

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.



The focus of most validation work is on the methodology, the standard operating procedure…

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.



The focus of most validation work is on the methodology, the standard operating procedure…

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.



This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well…