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Compliance4all
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  • Fremont, CA
  • United States
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A clear process for compliant laboratory OOS investigations

The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an…See More
Sep 12
Compliance4all posted a blog post

How to Recognize the Hazards of Blood Borne Pathogens

Bloodborne pathogens are those microorganisms present in the human blood that carry infection. These infections can cause disease in humans. The major bloodborne pathogens that cause infections in humans are:o  Hepatitis B (HBV)o  Hepatitis C (HCV)o  Human immunodeficiency virus (HIV)Although these are the main disease causing pathogens; there are many more. So, hospital staffs who deal with patients who are infected by…See More
Sep 8
Compliance4all posted a blog post

What is the legal language of the FDA form 1572 or Device equivalent?

Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.It is a contract in which the Principal Investigator, the person who is in charge…See More
Sep 6
Compliance4all posted a blog post

How to Achieve the best Outcome in an Audit

An internal audit, as we all know, is carried out for a number of specific purposes, the main one among which is to assess the adherence to the industry guidelines for quality and processes. Helping the organization meet the requirements of processes and standards, which are usually issued by regulatory agencies and other relevant bodies and boards, is the main aim of…See More
Sep 4
Compliance4all posted a blog post

cGMP Data Integrity is of Critical Importance

Of late, the FDA has been turning on the heat on manufacturers in the FDA-regulated industries that violate its regulations. It has a penchant for going after manufacturing facilities that show laxity in implementing current Good Manufacturing Practices (cGMP). This ardor is understandable. cGMP violations affect the quality of the product; hence the strictness, considering that it is patients who consume these products.There are ways of ensuring that the product meets the acute scientific…See More
Sep 1
Compliance4all posted a blog post

Techniques to Follow Which Increase the Confidence in the Audit

Auditing is a very important aspect of quality in all the areas of the medical sciences. An audit is the most reliable and foolproof method for evaluating the extent to which the various activities in an organization comply with the requirements and expectations the principal has from those to whom various processes are outsourced. Audits are the main tools for a quality unit to monitor and ensure that those activities are performed in compliance with the manufacturer commitments for quality…See More
Aug 29
Compliance4all posted a blog post

Tool for Checking Corporate Revenue Accounts Frauds

Corporate revenue account fraud and account manipulation are serious issues for businesses in many parts of the world today. Although legislations such as Sarbanes Oxley have been passed with the intention of making corporates more accountable; corporate accounting is still vulnerable to manipulation and fraud. A company’s financial statement is a primary area in which a fraud can happen.A financial statement is the elementary piece of documentation which reflects a company’s financial stature.…See More
Aug 22
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
Aug 16
Compliance4all posted events
Aug 16
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
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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

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

FDA Warns on Mixing Opioid Addiction Treatments, Other Meds

Posted on September 21, 2017 at 6:04am 0 Comments

TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.

The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.

The agency said…

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Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

Posted on September 20, 2017 at 6:27am 0 Comments

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…

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Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

Posted on September 19, 2017 at 6:05am 0 Comments

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…

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A common technique plots the data to help detect trends, cycles, and shifts

Posted on September 18, 2017 at 6:49am 0 Comments

Some of the functions of medical device manufacturers include:

o  Analyzing complaints

o  Processing data

o  Evaluating nonconformances

o  Utilizing other quality data sources.

The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…

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

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