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Compliance4all
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  • Fremont, CA
  • United States
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Compliance4all posted a blog post

The GDPR differs Significantly from EC Data Protection Directive 95/ 46

The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive…See More
Wednesday
Compliance4all posted events
Wednesday
Compliance4all posted a blog post

Relationship Between an EM Excursion Program and CAPA

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…See More
Aug 9
Compliance4all posted blog posts
Aug 8
Compliance4all posted blog posts
Aug 4
Compliance4all posted blog posts
Aug 2
Compliance4all posted a blog post

Ways of getting the PREDICT, ACE and the HTS right to smoothen shipping

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.PREDICT is an important tool that helps…See More
Jul 31
Compliance4all posted a blog post

Sources of contamination that exist in a clean room environment

Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for injections…See More
Jul 21
Compliance4all posted blog posts
Jul 20
Compliance4all posted blog posts
Jul 18
Compliance4all posted events
Jul 17
Compliance4all posted a blog post

Steps to IEC 60601-1 approval

The 60601-1 is a standard that relates to the safety of medical electrical equipment. This harmonized standard is recognized by most countries around the world. Existing and new medical devices have to comply with the requirements set out in IEC 60601-1.The IEC 60601-1 is going through its latest revision, its 3rd edition, which came into…See More
Jul 14
Compliance4all posted a blog post

How to control those risks and monitor the effectiveness of the controls put in place

Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A…See More
Jul 13
Compliance4all posted blog posts
Jul 12
Compliance4all posted a blog post

Guarding against cyberattacks

Data breaches, malware and related frauds can cost an organization very dearly. The effects of cyber fraud are rather alarming:It was estimated that cyberattacks amounted to a loss of at least a trillion dollars to the US economy in 2013, up by more than 25% over the previous year. The US continues to be the largest target and sufferer of cyberattacks. It accounts for more than a third of all cyberattacks that happen all around the world, followed by India, which is a distant second, at a ninth…See More
Jul 10
Compliance4all posted a blog post

Understanding and dealing with Automated Clearinghouses (ACH) frauds

Automated Clearinghouses (ACH) are a popular means of financial transactions, as they substitute actual physical paper documents such as cards and checks. ACH’s are an electronic network that facilitate and carry out a huge number of transactions online. In being online and quick; they have grown as a byproduct of the IT revolution and have gained popularity around the world for the ease of payments they…See More
Jul 7

Profile Information

Area of Expertise or Interest?
Compliance4All has experts who share a wealth of knowledge covering best practices in industry. These trainings help participants refresh their knowledge about regulatory compliance. Our panel of Experts imparts learning on a number of areas relating to compliance, such as:

Medical Devices
Pharmaceutical
Food
PCI industries, and
SOX

Our webinars cover the following Governing Areas:

FDA
GxP (Manufacturing/Clinical/Lab)
CMDR
EU
ISO
SOX and
PCI

These are the functional areas Experts from Compliance4All offer their expertise on:

Regulatory
Clinical Trials, and
Quality
Type of Affiliation?
Academia or NonProfit
Years of Experience in MedTech Field
10
About Me
Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.
Professional Objectives
Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.

Compliance4all's Blog

The GDPR differs Significantly from EC Data Protection Directive 95/ 46

Posted on August 16, 2017 at 5:32am 0 Comments

The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive…

Continue

Relationship Between an EM Excursion Program and CAPA

Posted on August 9, 2017 at 5:39am 0 Comments

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom…

Continue

Actions for Noncompliance of cGMPs in the Quality Control Laboratory

Posted on August 8, 2017 at 5:36am 0 Comments

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

Quality Control Laboratory 141216186486

 

Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors…

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Latest Trends in Human Error Issues in the Industry

Posted on August 7, 2017 at 5:40am 0 Comments

To say that the manufacturing industry is huge is to make a huge understatement. It is an activity that spans entire industries and is the lifeblood of many economies, right from advanced to developing ones. Despite the advancement in automation in the processes of many industries, manufacturing is still heavily dependent on human labor.

This makes manufacturing an activity that is prone to human error, because wherever there is human involvement, there is scope for human error. Why…

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At 8:47am on February 17, 2016, FRANK KWABENA said…

Good Day,

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