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Adam Fleaming
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  • Fremont, CA
  • United States
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Adam Fleaming posted blog posts
1 hour ago
Adam Fleaming posted a blog post

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

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 Guidance for Active…See More
Wednesday
Adam Fleaming posted events
Wednesday
Adam Fleaming posted blog posts
Tuesday
Adam Fleaming posted a blog post

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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming posted events
Aug 16
Adam Fleaming 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
Adam Fleaming posted blog posts
Aug 8
Adam Fleaming posted blog posts
Aug 4

Profile Information

Where do you live (city, state, country)?
NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
What industry do you work in?
compliance4all
What is your job title?
Event Coordinater
What company do you work for or associate with?
compliance4all
Do you currently use or recommend Personal Protective Equipment?
Yes
How did you find our online community?
through google
What best describes the role you play in the purchase of safety products?
Specify what hand protection to purchase, Use hand protection on my job, Make the actual glove purchases from a supplier, Other
If Other above, please explain.
it is very usefull

Adam Fleaming's Blog

The fourth season of Gurgaon's biggest & most popular food awards concludes with fervour

Some of the biggest names of India’s hospitality industry descended at the Hyatt Regency Hotel Gurgaon on Wednesday evening to celebrate the fourth season of ‘The Big F Awards’ – undoubtedly, Gurgaon’s biggest & most popular food awards.

The gala event was marked with the presence of bigwigs from the food & beverage…

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Posted on September 22, 2017 at 5:54am

FDA Warns on Mixing Opioid Addiction Treatments, Other Meds

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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Posted on September 21, 2017 at 6:02am

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

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…

Continue

Posted on September 20, 2017 at 6:26am

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

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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Posted on September 19, 2017 at 6:03am

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