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Adam Fleaming's Blog (133)

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…

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Added by Adam Fleaming on August 16, 2017 at 5:31am — No Comments

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…

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Added by Adam Fleaming on August 9, 2017 at 5:38am — No Comments

Actions for Noncompliance of cGMPs in the Quality Control Laboratory

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.

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

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Added by Adam Fleaming on August 8, 2017 at 5:35am — No Comments

Latest Trends in Human Error Issues in the Industry

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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Added by Adam Fleaming on August 7, 2017 at 5:39am — No Comments

The role of validation in HACCP

The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s…

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Added by Adam Fleaming on August 4, 2017 at 5:30am — No Comments

7 Keys to Compliance Excellence that Form the Foundation for Any Excellent Organization

In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:

  • It earns them a good reputation
  • Increases stakeholder and customer…
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Added by Adam Fleaming on August 3, 2017 at 5:47am — No Comments

MS Excel can be a wonderful tool for carrying out umpteen functions

Mastering MS Excel formulas and functions can make a miracle out of this program. When used optimally, MS Excel can be a wonderful tool for carrying out umpteen functions and optimizing work related to a number of departments. For example, the Accounts Department can do a number of important functions such as loan repayment calculation, generating a profit and loss statement, solve complex mathematical and engineering problems, and carry out anything that involves addition, subtraction,…

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Added by Adam Fleaming on August 2, 2017 at 5:34am — No Comments

Understanding HACCP and risk based HACCP

Hazard Analysis and Critical Control Point (HACCP) is an important system aimed at bringing down the risk of safety hazards found in food consumed all over the world. It is an internationally recognized system. When it was enacted in January 2011 as part of the FDA’s Food Safety Modernization Act; it was considered a very sweeping piece of legislation for the food industry.

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Identification and control of…

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Added by Adam Fleaming on August 1, 2017 at 5:38am — No Comments

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…

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Added by Adam Fleaming on July 31, 2017 at 5:27am — No Comments

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…

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Added by Adam Fleaming on July 31, 2017 at 5:27am — No Comments

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…

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Added by Adam Fleaming on July 31, 2017 at 5:27am — No Comments

Understanding and applying ICH Q3A and Q3B

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared by the ICH, which this FDA guideline complements. This is why the documents get their name. The FDA keeps revising these documents from time to time. After every revision, the latest version carries the added taxonomy of “R” to denote that the guidance is a revised one.…

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Added by Adam Fleaming on July 25, 2017 at 5:31am — No Comments

How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of…

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Added by Adam Fleaming on July 24, 2017 at 5:16am — No Comments

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…

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Added by Adam Fleaming on July 21, 2017 at 6:07am — No Comments

Understanding opportunities in NAFTA

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and…

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Added by Adam Fleaming on July 20, 2017 at 5:24am — No Comments

How to create processes and procedures to implement them?

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.

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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 rigorous…

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Added by Adam Fleaming on July 19, 2017 at 5:45am — No Comments

Why is credit card surcharge an issue for businesses?

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited credit card surcharge in ten States. Another 12 States are in the process of implementing their laws.

Although credit card regulations have traditionally opposed surcharging; companies have been circumventing merchant rules to ensure that credit card surcharge continues to be made. Even…

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Added by Adam Fleaming on July 18, 2017 at 5:25am — No Comments

Understanding GLP's and their relationship with GMPs and SOP’s

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

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GLP’s are Quality…

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Added by Adam Fleaming on July 17, 2017 at 5:37am — No Comments

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,…

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Added by Adam Fleaming on July 14, 2017 at 6:26am — No Comments

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…

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Added by Adam Fleaming on July 13, 2017 at 5:42am — No Comments

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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
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Laboratory Compliance webinar for $10 each at Online

August 16, 2017 at 10am to December 31, 2017 at 11am
Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many…See More
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rodriguezcecelia posted a blog post

How PMP Certification impact Your Salary?

Before investing money and time in PMP certification, it is very important for anyone to understand how the certification will impact salary. In this article, we will discuss PMP certification and its effects on salary, which can help you to decide whether you should go for it or not. We will focus on different perspectives of PMP salary, which is based on experience, the size of the company, designation and many others. Overview of PMP CertificationThough the PMP certification salary hike is…See More
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Safety - A Prerequisite 11 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by Tara safe 9 hours ago.

Lean Six Sigma Black Belt Training in New York City

Welcome to MSys Training! We thank you for visiting MSys LSSBB training page. Attend our 4 days Lean Six Sigma Black Belt (LSSBB) training program with 100% pass rate, high quality course material,…Continue

Tags: sigma, six

Started by rodriguezcecelia on Friday.

ITIL Certification Training - MSysTraining

The ITIL® Foundation is an entry level qualification in Information Technology industry. It gives participants information about the key elements, terminologies and concepts used in the ITIL Service…Continue

Tags: itil

Started by rodriguezcecelia Aug 8.

Snowflake and Star Schema in Qlikview

In big name schema all of the facts are stored in one important table and the usage of number one key and overseas key courting different measurement tables are related with the fact desk.SNOWFLAKE…Continue

Tags: processing, transactional, qlikview

Started by Soujanya Naganuri Jul 25.

What is Class Structure in Pega?

Class contains the rule by way of which objects behave. outline rules such as houses, sports, flows, html paperwork, etc. to be had to different subordinate classes. lessons are organized into a…Continue

Started by Soujanya Naganuri Jul 17.

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