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John Robinson's Blog (65)

Safety Management and OSHA Compliance

Safety Management and OSHA Compliance 1

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…

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Added by John Robinson on June 28, 2017 at 6:17am — No Comments

Documenting Software for FDA Submissions

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The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:14am — No Comments

All about biosimilars –from development to registration

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Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…

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Added by John Robinson on June 27, 2017 at 6:01am — No Comments

HIPAA compliance expectations from Small Healthcare Providers

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Added by John Robinson on June 14, 2017 at 6:27am — No Comments

Change Control is at the core of GMP Compliance

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Added by John Robinson on June 13, 2017 at 6:46am — No Comments

Quality by Design using Design of Experiments

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Added by John Robinson on June 8, 2017 at 6:47am — No Comments

Writing and implementing effective SOP’s

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Added by John Robinson on June 6, 2017 at 6:35am — No Comments

Validation the complies with ICH guidelines



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Added by John Robinson on June 5, 2017 at 7:24am — No Comments

Four years of the EU’s Cosmetics Product Regulation

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Added by John Robinson on June 2, 2017 at 6:17am — No Comments

Seminar Calendar of Upcoming Courses - June to July - 2017

 

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the…

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Added by John Robinson on May 24, 2017 at 5:51am — No Comments

“Understanding the practical application of statistics?”

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:

o  Setting validation criteria and specifications

o  Performing…

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Added by John Robinson on May 19, 2017 at 5:51am — No Comments

Knowledge of employment laws is absolutely crucial for organizations

As the new presidential administration settles in in the US, employment law…

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Added by John Robinson on May 17, 2017 at 5:56am — No Comments

Marketing and promotion of drugs and medical devices

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Added by John Robinson on May 16, 2017 at 6:22am — No Comments

Key issues in HR auditing

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Added by John Robinson on May 15, 2017 at 5:36am — No Comments

HIPAA’s compliance expectations from Business Associate

The Health Information Portability and Accountability Act (HIPAA) regards the Business Associate as a major player. HIPAA defines the Business Associate (BA) as either an organization or a person who works with or provides service to a Covered Entity, who in turn is defined as one who handles or discloses Protected Health Information (PHI).

So, a Business Associate is any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a Covered Entity for…

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Added by John Robinson on May 11, 2017 at 8:23am — No Comments

Understanding the FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

The establishment of the initial safety of a drug is the primary reason for which early clinical trials are conducted. Phase I of drug development consists of:

o  Research and drug…

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Added by John Robinson on May 9, 2017 at 6:04am — No Comments

Technical training in the life sciences

It is accepted that Training and Development is a highly developed area that bring its own body of knowledge. It uses a wide variety of techniques and approaches that are designed to meet the unique and complex challenges associated with training.…

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Added by John Robinson on May 8, 2017 at 7:57am — No Comments

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CAPM - 4 days Classroom Training in San Diego at 3927 8th Avenue

July 25, 2017 at 9am to July 28, 2017 at 5pm
Welcome to MSys Training! We thank you for visiting MSys CAPM training page. Attend our 4 days Certified Associate in Project Management (CAPM®) training program with 100% pass rate, high quality course material, 5 simulations and much more. Visit www.trustpilot.com to read reviews from our participants. We offer PMP, LSSGB, LSSBB, PMI-ACP, ITIL Foundation, Big Data and Hadoop, Digital Marketing and other certification programs every…See More
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Advantages and disadvantages of Electronic Health Records

Electronic Health Records (EHR) or electronic medical records (EMR), as they are called, are of enormous use in the fields of healthcare and medical sciences. They have a number of features that enable the patient; the medical professional and the healthcare provider have complete and unimaginably easy access to all important records that relate to the patient.A direct result of the development of…See More
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Forum

SQL Server Windows Management Instrumentation Tasks

Hello,SSIS includes two special tasks that enable you to query system information and monitor system events: the WMI Data Reader Task and the WMI Event Watcher Task. These tasks are especially useful…Continue

Tags: Task, WMI, Server, SQL

Started by Madison Quinn Jun 20.

difference between NEBOSH and IOSH

NEBOSH “National Examination Board in Occupational Health and Safety”IOSH “Institution…Continue

Tags: kerala, IGC, NEBOSH

Started by mani May 31.

What's your favorite motivational/safety quote? 98 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David R Snell Apr 26.

Feedback on a injury prevention product we're building.

Hi everyone!For full transparency ill tell you a little about myself and what I hope to accomplish. My name is Zuber and I'm an engineering student who founded a startup helping to build wearable…Continue

Tags: product, prevention, injury, back, safety

Started by Zuber Ahmed Apr 24.

Best overall personal safety book? 1 Reply

What do you think is  the best all-in-one book out there for optimizing personal safety and the safety of one's family?  Right now I have …Continue

Started by David R Snell. Last reply by David R Snell Apr 21.

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