Working With The FDA - The FDA Warning Letter Process

• People also need FDA GMP Online Training - trusted FDA CGMP online training programs offered by SkillsPlus International Inc.

Updated June 12, 2021

The original link broke.

You can still read about this topic here:

Working With The FDA - Manufacturing.net

---  the original post follows below  ---

A nice quick and easy introductory article about FDA Warning Letters.

Working With The FDA | Pharmaceutical Processing:

"According to FDA, warning letters are sent as a way of encouraging companies to voluntarily comply with industry standards and regulatory guidelines. In that regard, they are a way of establishing a public record of the agency’s conversations with members of the industries it regulates.

Generally warning letters are sent following a routine or complaint-triggered inspection. Upon completion of an inspection, investigators may issue Form FDA-483 which documents any deficiencies found at a facility. Company officials will then be able to initially respond either through an exit discussion and/or a formal written response. Agency inspectors will also draft an Establishment Inspection Report (EIR), providing more detail on inspection observations and linking them to any evidence collected from the affected firm’s facility. Once the EIR and Form 483 are reviewed by senior FDA officials, a warning letter may follow."

'via Blog this'

You might also be interested in:
Surviving an FDA Inspection - A highly recommended training course taught by the best instructors

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Good Manufacturing Practices Creative Ideas for Teaching GMP - Free Tip

• FDA cGMP QSR GMP Training - online training classes by SkillsPlus International Inc.

Updated October 12, 2020

The original link broke.

- - -  original post follows below  - - -

Good Manufacturing Practices Creative Ideas for Teaching GMP By Madison Area Technical College Biotechnology Department Back To GMP:

"Documentation, that is, a system of written records, is essential in all laboratories and production environments. A Standard Operating Procedure (SOP) is a certain type of document that describes in a step-by-step outline form how to perform a particular task or operation. Everyone in a company must follow the same procedures to assure that tasks are performed consistently and correctly. Most companies have a wide variety of SOPs that describe how to do different tasks. In many companies technicians and operators are trained in how to follow individual SOPs and their training record specifies which SOPs they are trained on and are authorized to use."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• P.R. China - Good Manufacturing Practice for Drugs (2010 Revision) - In English - Free (drughealth.blogspot.com)
• Highly Recommended QSR & GMP Trainer Certification (skillsplusinfo.blogspot.com)
• What is the Cost of GMP Compliance? (drughealth.blogspot.com)

When Does An App Need FDA's Blessing?

When Does An App Need FDA's Blessing? : Shots - Health Blog : NPR:

"As a result, the Food and Drug Administration has concluded that at least some apps should undergo review by the agency before being permitted on the market. "There are many mobile apps that are on the market that are medical devices," Dr. Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health. "There are apps today that change a mobile platform into an EKG machine. When it's being used to diagnose patients, it's a medical device we believe subject to FDA oversight."

But Shuren stresses that the FDA has no plans to review most apps, such as those that help with wellness, healthier lifestyles. Same goes for thoseused to help patients manage their medical conditions. "The risk to patients are very, very low," he says.

Some app makers, however, say they can't be sure what's allowed. "The problem is now we live in this era of connected health where everything is being connected to everything else," said Bradley Merrill Thompson, a lawyer who represents some app makers. "So now that you've got this ecosystem where everything is connected to everything else. That's what creates this ambiguity with FDA.""

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• FDA regulators face daunting task as health apps multiply (drughealth.blogspot.com)

Highly Recommended QSR & GMP Trainer Certification - SkillsPlus International Inc.

Updated March 14, 2021:

Did you miss our public seminar? Give us a call: (415) 948-5220, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

---

Highly Recommended QSR and GMP Trainer Certification | SkillsPlus International Info:

"GMP and QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

Refine your skills and become the best QSR or GMP trainer that you can be!

Learn about things to do in San Francisco:  San Francisco Travel for Visitors

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - Popular GMP training, recommended QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• 
  The Best GMP Training - Look No Further! - SkillsPlus International Inc.

  ---

• 
  QSR and GMP Training Online - Classes by SkillsPlus Intl Inc

  ---

• 
  What is the Cost of GMP Compliance?

  ---

FDA Consumer Updates - Should You Put Sunscreen on Infants? Not Usually

FDA Consumer Updates > Should You Put Sunscreen on Infants? Not Usually:

"You're at the beach, slathered in sunscreen. Your 5-month-old baby is there, too. Should you put sunscreen on her? Not usually, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

"The best approach is to keep infants under 6 months out of the sun," Sachs says, "and to avoid exposure to the sun in the hours between 10 a.m. and 2 p.m., when ultraviolet (UV) rays are most intense.""

'via Blog this'