Online Safety Community

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major culprit when it comes to losses that many industries sustain in their quality and production. Technology has pervaded most industries in ways that were not imaginable a couple of decades back; yet, it is not likely that human error will ever be totally eliminated.

error-metaphor-teamwork-concept-separated-white-31189596

Having said this, it is also true that it is possible to prevent several human performance problems. The starting point of human errors start is the design stage. Human reliability comes into play in a major way in procedures. The key to human engineering, improving and/or fixing and identifying exactly where the weaknesses in the procedures instructions lie is getting a grasp of human behavior and the psychology of error.

A learning session on all the aspects of writing for GMP regulations

An understanding of the weakness in procedures that harm productivity, quality and regulatory standing will be the major learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Ginette Collazo, a human error and human behavior expert, who brings vast experience in the technical training, organizational development and human reliability areas. Interested in gaining insights into how to understand and reduce human errors in GMP procedures? Then, all that you need to do is to register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501285L...

Discussion of all the areas of human error in writing for GMP regulations

At this webinar, Ginette will discuss everything from content development to formats designed for human error reduction due to procedures. She will start with an outline of SOP writing and describe the role and possibility of human error in content development. She will also discuss the universal purpose of procedures in the background of regulatory compliance.

Ginette will expound the human perspective and the rational for procedure use and describe human error as a root cause. She will also explain the thinking and reading process and touch upon some common mistakes and causes.

Human error rates and measurement, the ways of creating and maintaining a procedure, as well as the goals of a procedure, will all be taken up.

Taking a glimpse at Good Procedure Writing practices

Another of the areas Ginette will traverse during the course of this very interesting session is Good Procedure Writing practices, during which she will dwell upon all its related aspects such as Terminology, Formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions”.

Finally, she will also explain procedure styles and the use of electronic information networks for procedure access. All in all, this promises to be a very educative and well-rounded teaching session. All the important people involved in GMP regulation and human factors, such as QA/QC Directors and Managers, Process improvement/excellence Professionals, Training Directors and Managers, those in Plant Engineering, Compliance Officers, Regulatory Professionals, people in Executive Management, Manufacturing operations Directors and Human factors Professionals, will all derive benefits in large measure from this webinar.

Views: 20

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Training Doyens posted events
1 hour ago
Training Doyens updated an event
Thumbnail

Form I-9 Compliance at 26468 E Walker Dr, Aurora, Colorado 80016-6104

January 25, 2018 from 1pm to 2pm
OVERVIEWDon't spend another day worrying that you and your organization might end up in legal trouble from immigration law violations. The crucial information provided in this one-hour webinar will give you the knowledge and know-how needed to ensure your documentation is filled out appropriately, your records are kept correctly and your organization is legally compliant.WHY SHOULD YOU ATTENDImmigration law is one of the most pertinent and publicized issues in the United States right now.…See More
2 hours ago
John Robinson posted a blog post

The FDA's requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical productshttps://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-fdas-requirements-for-non-ind-foreign-clinical-studies-2.jpg?w=800&h=504…See More
21 hours ago
Training Doyens posted an event
Thumbnail

Excel - Pivot Tables 101 at 26468 E Walker Dr, Aurora, Colorado 80016-6104

December 20, 2017 from 1pm to 2:30pm
OVERVIEWPivot Tables are one of the most powerful tools in Excel’s data analysis and Business Intelligence (BI) armory. With just a few clicks of the mouse (and no complicated formulas!) you can quickly and easily build reports and charts that summarize and analyze large amounts of raw data and help you to spot trends and get answers to the important questions on which you base your key business decisions.WHY SHOULD YOU ATTENDLearning how to create Pivot Tables is one of the must have skills…See More
yesterday

Forum

PEGA Axis error: Parser already accessed

We have a PEGA frontend, from in which we're keying in double byte characters like japanese and being send to allotted java webservice through axis. this is working best when we ship singlebyte…Continue

Tags: pega_training, pega_online, pega

Started by Soujanya Naganuri on Thursday.

VMware player error on install vmware tools.

 I've installed the last version of VMware player (4.0.2) and created a virtual machine with ubuntu 10.04. However, some operations with …Continue

Tags: training, online, vmware

Started by emmablisa Dec 1.

All About QlikView

QlikViewQlik relies on sophisticated analytics that enables data discovery using an in-memory engine to analyze data for patterns not visible via SQL data structures or queries. The company’s two…Continue

Tags: Safety, Qlikview

Started by nicolewells Nov 25.

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe Nov 16.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells Nov 15.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service