Two candidates on Trump short list for FDA commissioner - BioCentury.com

Read the full article: Two candidates on Trump short list for FDA commissioner - BioCentury.com:

"President-elect Donald Trump's transition team has two candidates on the short list for FDA commissioner, a source on the team told BioCentury. In addition to Scott Gottlieb, a resident scholar at the American Enterprise Institute who previously has been tipped for the job, the team is considering Jim O'Neill, a managing director at Mithril Capital. That firm was co-founded by Peter Thiel, a Silicon Valley entrepreneur who was an early backer of Trump's presidential campaign. "

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Millennials and Compliance: Their Perspective - The Compliance & Ethics Blog

• FDA GMP Online Training - recommended CGMP online training courses provided by SkillsPlus International Inc.

Read the full article: Millennials and Compliance: Their Perspective - The Compliance & Ethics Blog:

"Millennials who had observed serious misconduct, more than two-thirds reported it, including such offenses as theft, falsifying expense reports or time sheets, harassment or abuse, and bribery. Millennials, like any other employee, know when something is wrong, illegal, or will harm the company. They simply do not see that social media is “harmful,” any more than older employees viewed gossiping at the bar on Friday night was “harmful.”"

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FDA’s Draft Quality Metrics Guidance, Version 2.0 - FDA Law Blog

Read the detailed analysis: FDA Law Blog: FDA’s Draft Quality Metrics Guidance, Version 2.0:

"In conclusion, the modifications made to the revised Draft Guidance are substantial (indeed, even the name of the document was changed). It will be interesting to see whether the quality metrics reporting program, a cornerstone of FDA’s framework for building quality into drug products, advances as planned.  The path for the program over the next few years is perilous, whether the agency seeks to finalize it via notice and comment rulemaking or simply via guidance."

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FDA finalizes quality guidelines for contract manufacturers | BioPharma Dive

Read the full article: FDA finalizes quality guidelines for contract manufacturers | BioPharma Dive:

"In its 16-page document, FDA also explains that Current Good Manufacturing Practice (CGMP) requirements apply to all contract facilities, including analytical testing labs."

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View the published guidance document:
Contract Manufacturing Arrangements for Drugs: Quality Agreements - FDA Guidance for Industry (PDF)

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Root Cause Analysis - cGMP Free Tip

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

GMP Free Tip on Root Cause Analysis (RCA)

The FDA says, "Human error is not a root cause." If your first reflex is blaming human error, it's time to re-think the situation in order to identify the real root cause of the human error.

There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.

Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).

Learn more about this topic by taking these courses by SkillsPlus Intl Inc:
Root Cause Analysis for Better Investigations - A cGMP QSR GMP Training Course
Deviation Investigation Report Writing - A GMP QSR cGMP Training Workshop


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FDA GMP QSR cGMP Training Courses and Workshops

FDA cGMP QSR GMP Training Course Catalog

Prevent an end-of-year training scramble next year, by starting your training planning now.

CGMP training courses offered by SkillsPlus International Inc.

Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses

View our SkillsPlus Intl Inc. FDA QSR GMP training class & workshop offerings (PDF)  

#FDA #QSR #cGMP #GMP #training #courses #classes #workshops #seminars

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Emerging Issues and Cross-Cutting Scientific Advances - FDA; Establishment of a Public Docket - Federal Register

• FDA GMP online training courses, classes, and programs offered by SkillsPlus International Inc.

Go to the full notice: Federal Register :: Emerging Issues and Cross-Cutting Scientific Advances; Establishment of a Public Docket - FDA:

"The Food and Drug Administration (FDA) is establishing a public docket to receive input on emerging issues and cross-cutting scientific advances that may impact FDA preparedness and inter-Agency activities. Interested parties are invited to submit comments regarding emerging technologies and cross-cutting scientific advances of importance to FDA. The focus is on areas that may impact FDA in 5 or more years."

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FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews

• FDA cGMP online training programs, courses, and classes offered by SkillsPlus International Inc.

Read the full article: FDA floats new draft guidance, created by international group, on software as a medical device | MobiHealthNews:

"The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest."

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View the draft guidance:
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability

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Advanced cGMP Training - Root Cause Analysis & Deviation Investigation Reports

Updated June 29, 2020

You asked for it, and we've delivered!

Root Cause Analysis and Investigation Report Writing - an online self-study course

The most popular class with Allan Dewes, "Root Cause Analysis and Investigation Report Writing" is now available as an online self-study course. In 3-1/2 hours you'll learn about the tools used to conduct a thorough deviation investigation. You'll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.


About the Coaching Option (an advanced option) 

• This optional purchase enables the student to practice each tool or report section. Each item is submitted to Allan for his review and evaluation. The student receives feedback. The purchase buys the student 4-hours of email-based coaching from Allan. Additional 4-hour blocks can be purchased if needed.

Pricing | Questions

• If you have questions, call us: (415) 948-5220 

- - -  original post follows below  - - -

Advanced cGMP Training

Advanced GMP Training - Root Cause Analysis & Deviation Investigation Report Writing

Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.

• Throwing fixes at the wrong things might not fix the problem.
• Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.

By taking our advanced courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

These highly popular advanced cGMP training classes are taught at the location of your choice. You might be interested in two of our highly inter-related courses.

Root Cause Analysis for Better Deviation Investigations: On-site Advanced GMP Training by SkillsPlus International Inc.  

     Course Objectives:

• Use tools and techniques to effectively identify the deviation statement
• Identify the root cause of the deviation. 
• Generate and objectively select the best corrective and preventive actions.
• Assess the risk of implementing the corrective action and preventive action.
• Develop a contingency plan to preventive action implementation.
• Create corrective actions and preventive action metrics. 

Deviation Investigation Reports: On-Site Advanced GMP Training by SkillsPlus International Inc.
      Course Objectives:

• Increase investigation report suitability for FDA review. 
• Decrease the number of reports returned by internal reviewers. 
• Write supported deviation statements. 
• Provide a detailed background statement to include related information, investigations, affected materials and references. 
• Document deviation investigation findings. 
• State the root cause with supporting facts. 
• Generate supported, plausible, and defensible corrective actions. 
• Develop effectiveness measures for the corrective actions. 
• Generate realistic preventive actions. 
• Develop effectiveness measures for the preventive actions. 
• Develop a follow up plan for corrective and preventive actions. 
• Write accurate executive summary statements. 

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Advanced cGMP Training Courses & Classes

Advanced GMP Training

Advanced GMP Training Workshops & Seminars

SkillsPlus International Inc. offers both advanced and basic GMP training courses and classes. While serving over 350 clients and customers world-wide (in the pharmaceutical, biotech, and medical device industries), it is our mission to provide quality training and consulting services that meet the needs of the client organization.

Do you have an advanced cGMP training need?  Then give us a call to see how we can help you:  (415) 948-5220.


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#FDA #cGMP #GMP #training #basic #advanced #courses #classes #workshops #seminars

GMP Basics for Beginners & Experienced Team Members - cGMP Training Course

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

cGMP Basics Training Course for Beginners, and Experienced Professionals

Naturally you'll want your new hires introduced to the basics of the FDA cGMP regulations.

Don't forget that your experienced team members need occasional doses of GMP refresher training too!

You might be interested in our cGMP training course:

 
"Essentials for Pharmaceutical Manufacturers."

GMP training for beginners and experienced team members

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You might also be interested in:

cGMP training for beginners and experienced professionals

SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Root Cause Analysis - GMP Training
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8th Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - U.S. - mondaq.com

Read the full article: Eighth Circuit Issues Decision Significant For All Executives Of FDA-Regulated Businesses - Consumer Protection - United States - mondaq.com:

"Judges Murphy and Gruender explained, RCO liability bears on the blameworthiness of a corporate officer who failed to prevent or remedy the condition at issue. And any executive operating in the highly regulated world of food and drugs, where widespread harm can be the outcome of corporate negligence, has a “heightened degree of foresight and care.”"

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RCO = responsible corporate officer

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FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law

Read the full article: FDA Announces Inspection Procedure Change for 503A Compounders | Frier Levitt - Attorneys at LawFrier Levitt – Attorneys at Law:

"Effective August 1, 2016, FDA investigators now will make a preliminary assessment regarding a compounder’s compliance with conditions of section 503A and will not include observations that represent deviations solely from CGMP requirements unless the investigator’s assessment is that the compound drugs do not qualify for the exemptions under section 503A."

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Read the details of the FDA Notice (PDF)

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FDA to Drug Compounders: Inspection Changes Coming in August | RAPS

• Recommended FDA cGMP online training courses, classes, and programs sold by SkillsPlus International Inc.

Updated October 8, 2022

You might also be interested in:

Human Drug Compounding - FDA.gov

---  the original post follows below  ---

Read the full article: FDA to Drug Compounders: Inspection Changes Coming in August | RAPS:

"For companies that compound human drugs in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B), effective 1 August 2016, “FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.”"

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Read the details of the FDA Notice (PDF)

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Technical Considerations for Additive Manufactured Devices - FDA.gov

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Recent Draft Medical Device Guidance Documents - FDA.gov:

"Technical Considerations for Additive Manufactured Devices - Draft Guidance for Industry and Food and Drug Administration Staff" (PDF)

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Priorities – Teamwork to Achieve Common Goals | FDA Voice

Read Dr. Califf's Priorities – Teamwork to Achieve Common Goals:

"With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success."

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Data Integrity and Compliance w/cGMP - FDA Newly Added Guidance Documents

Go to the FDA website: Guidances (Drugs) > Newly Added Guidance Documents - FDA.gov:

Read this newly posted FDA guidance:
"Pharmaceutical Quality/Manufacturing Standards (CGMP) - Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) - Draft Guidance -  04/14/16"

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