2014 GMP Training Ideas - Deviation Investigation Report Writing Workshop

483 Observation Gotchas!

1. Deviation reports failed to include a discussion of product impact.

2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.

3. Investigation reports failed to provide data to support the root cause determination

Planning for Training 2014!  2014 is just around the corner!  Do your investigation reports wander all over and never get to the point, or Do deviation reports fail to document a sound root cause conclusion, or Do deviation report writers never seem to know what Quality Assurance wants discussed in the report? If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic. Learn More About the SkillsPlus Investigation Report Writing Clinic

Featured Course Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered. Common sections addressed in this very popular workshop: 1. Deviation Description 2. Previous Related Investigations 3. Product Impact Assessment 4. Root Cause Investigation Discussion 5. Root Cause Determination 6. Risk Assessment 7. Corrective and Preventive Actions and more! If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic! Examine The SkillsPlus Investigation Report Writing Clinic Outline

Allan Dewes, President. About Your Instructor Allan Dewes Allan Dewes has been teaching others to write deviation investigation reports for over 15 years. Allan understands CGMP regulations, the FDA expectations for deviation investigation reports, and how to coach others to write a quality document. Email today to request a quotation

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FDA Focusing On Food & Drug Manufacturing GMP Compliance

• Respected FDA CGMP online training courses and programs by SkillsPlus International Inc.

Updated December 9, 2021

Links in the original post broke.

You might also like:

Current Good Manufacturing Practice (CGMP) Regulations - FDA.gov

Compliance & Enforcement (Food) - FDA.gov

---  the original post follows below  ---

FDA is focusing on cGMP compliance by food and drug manufacturers.

FDA investigative chief eyes manufacturing practices:

"John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.

The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.

"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way.""

'via Blog this'

You might also be interested in:
On the FDA website - FD&C Act Chapter III: Prohibited Acts and Penalties

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The Exemptee Institute
The Designated Representative Institute

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The Only Vote That Counts: FDA 483 Round-Up

The Only Vote That Counts: FDA 483 Round-Up:

"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."

'via Blog this'

You might also be interested in:
Root Cause Analysis for Better Investigations - Live On-Site Training Course

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Related articles

• FDA's Top Supplement Issues (drughealth.blogspot.com)

FDA Warning Letters in 2011 Mostly Focused on Batch Failures

Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures - RAPS - News - Article View:

"An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure investigation, reports In-Pharma Technologist.

“In the manufacturing-related warning letters analyzed by in-Pharma Technologist, FDA made 211 numbered observations,” of which 10% were related to the company not investigating batch failures."

'via Blog this'

You might also be interested in:
Faster Product Release Through Efficient Batch Record Review - Onsite Training Class
Root Cause Analysis for Better Investigations - Onsite Training Class

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Related articles

• 2011 FDA Warning Letter Review (drughealth.blogspot.com)

Free Tips On Preparing For An FDA Inspection

Here's a good article from Bruce McDuffee, Tips on Preparing for an FDA Inspection - Are you following current good manufacturing practices?

References he mentions:
FDA form 482
Investigations Operations Manual (IOM)

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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Top 10 - Reasons Why CAPA or Deviation Investigation Systems Fail

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

I ran across this post on The QA Pharm Blog,  The Top Ten Reasons the Deviation Investigation System Fails. It's a good read amongst some other pretty thought-provoking posts.

In a nutshell:

"Warning Letters are fraught with observations that point to issues with the deviation investigation system and the ability to solve problems once and for all. Here are my top ten reasons that the deviation/investigation/CAPA system fails: . . . "

You might also be interested in:
Root Cause Analysis for Better Investigations by SkillsPlus Intl Inc.

#FDA #GMP #cGMP #training #course #class

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inShare

Clinical Study Of Disulfiram To Reduce HIV Reservoir

Image via WikipediaThis caught my eye while scanning health news, Short-term Disulfiram Administration to Accelerate the Decay of the HIV Reservoir in Antiretroviral-treated HIV Infected Individuals.

This ClinicalTrials.gov notice provides robust details about the research study, which is actively recruiting participants.

I find the basis for the study pretty interesting:

"Our primary hypothesis is that disulfiram will reduce the latent reservoir of HIV-1 in patients on highly active antiretroviral therapy (HAART). Theoretically, disulfiram will force HIV to replicate (grow) and thus result in the death of the infected cell. Standard antiretroviral drugs should prevent new cells from becoming infected. The end result of this process is that the total amount of HIV in the body will decline over time."

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Learn From 2010 FDA Warnings To Pharma Companies

• FDA CGMP Online Training - recommended GMP online training classes offered by SkillsPlus International Inc. (a regulatory compliance training provider)

2010 is now behind us.  It's time to turn your attention to 2011. If you're in the FDA GMP training space, consider leveraging the following resource in your GMP trainings:  FDA Inspections, Compliance, Enforcement, and Criminal Investigations - Warning Letters.

From this main Warning Letters page, you can research and learn from the warning letters, that can be found by:

• Year
• Company
• Subject
• . . . and many other advanced search criteria

The Warning Letters can be used as great examples of just how important it is to comply with the regulations.

You might also be interested in:
Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

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FDA Says Watch Out For Fake Alli Capsules

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

The U.S. Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).  The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
• Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Related Posts:
Counterfeits In The Global Drug Supply

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