6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

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According to the article:

"The journey to industry compliance with the U.S. Drug Supply Chain Security Act (DSCSA) continues to twist and turn with recent requirements going into effect for distributors and dispenser and subsequent delays on enforcement of some of those requirements until Nov. 27, 2023."

"The discussions and perspectives in the meeting were often conflicting and sometimes seemed to ignore insights developed over the past years by several industry workgroups. We would like to suggest some concrete actions the FDA can take now to help bring together a complex and diverse number of sectors in advance of 2023 enforcement:"

Read the full source article:  6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

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Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections - FDA Law Blog

Read the entire article: FDA Law Blog: Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections:

"Such specialized investigators may be more adept and knowledgeable at identifying issues, making for undoubtedly “smoother inspections” instead of flailing around.  But just because an inspection may be smoother, it does not mean that there will be happier consequences for the affected facilities."

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#FDA #cGMP #GMP #training #courses #classes

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SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies | The National Law Review

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Read the full article: SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies | The National Law Review:

"In a wide-ranging speech on Tuesday, Securities and Exchange Commission Director of Enforcement Andrew Ceresney discussed recent SEC actions and current concerns involving the pharmaceutical and medical technology industries. Ceresney’s speech is noteworthy because it highlights areas that are getting particular attention from the SEC’s Enforcement Division, namely the Foreign Corrupt Practices Act, internal controls and accounting, and disclosure of dealings with the Food and Drug Administration."

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Onsite cGMP Training - Olympics for Pharmaceutical & Biotech Manufacturers

Updated June 5, 2021

Given the COVID-19 pandemic, people are also interested in:

FDA GMP Online Training - respected FDA CGMP online training courses presented by SkillsPlus International Inc.

---  original post follows below  ---

Onsite cGMP Training -  Olympics for Pharmaceutical & Biotech Manufacturers - by SkillsPlus International Inc.

How many boring training classes have you and your colleagues been through?!

Say NO to boring training. Experience exciting, energizing, and engaging training!

Take a deep dive to a deeper level of understanding through a series of challenging activities.

By the end of this class, energized students will be able to:
1. List the hottest issues in CGMP compliance.
2. Locate items of interest in 21CFR211.
3. Explain the 21CFR211 rationale for specific 483 observations.
4. Demonstrate knowledge of common CGMP practices and details.
5. State the consequences of not following CGMPs.

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Management Session: What Every Manager Needs to Know - GMP & QSR Training

Updated June 6, 2025

The course highlighted is no longer available. 

You might also be interested in these online GMP training courses:

https://gmpprof.com/cgmp-training-a-new-generation/

---  the original post follows below  ---

Management Session: What Every Manager Needs to Know - is a live onsite GMP & QSR training class by SkillsPlus International Inc.   This is an instructor led course, taught on-site in-house in-plant at the locations of your choice.

Know your stuff and lead with confidence!

This course addresses CGMP and QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

Upon completion of this class, you'll be able to:
1. State the common 483 observations issued by the FDA.
2. List the basic requirements of CGMP or QSRs that require the attention of the leadership team.
3. Identify gaps in compliance.
4. Identify the issues that needs to be rectified.

For more information, visit:
Management Session: What Every Manager Needs to Know - training by SkillsPlus International Inc.

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• Executive Session: What Leadership Needs to Know - Onsite cGMP & QSR training (skillsplusinfo.blogspot.com)

Faster Product Release Through Efficient Batch Record Review - Onsite cGMP & QSR Training Class

Updated March 17, 2023

The batch record review course is no longer available.

You might also be interested in FDA cGMP online training programs and courses offered by SkillsPlus International Inc.

---  the original post follows below  ---

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

This is a live on-site class. It is instructor-led and taught at the client location of your choice.

Purpose:
This live on-site GMP & QSR training class teaches students how to competently review batch records to identify errors and issues.

Objectives:
Upon course completion, students will be able to:
 1. State the source of batch record requirements for both US and EU
 2. Distinguish between the production and QA batch record review
 3. List best practices in Batch Record Review
 4. Demonstrate at least 5 different batch record review activities.

Topics include:

1. Regulation review 
2. US & EU Requirements and Regulatory Expectations 
3. Best Practices 
4. BPR Regulations Background 
5. BPR Audit Items: Skills Practice 
6. Trending

For more information, visit:

Faster Product Release Through Efficient Batch Record Review - Live onsite cGMP & QSR training by SkillsPlus International Inc.

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Additional Keywords: biotech, cGMP, class, compliance, device, DME, drug, energizing, engaging, exciting, FDA, GMP, instructor, interactive, manufacturer, medical, ,pharmaceutical, QSR, SkillsPlus, trainer, training,

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Batch Record Review Training - a live cGMP class

• People also prefer online training - FDA CGMP online training courses provided by SkillsPlus International Inc.

Updated August 17, 2022

The batch record review course is no longer available.

You might also be interested in our other cgmp online training programs and courses.

---  the original post follows below  ---

GMP Training - Batch Record Reviewing - cGMP Training

Learn how to review batch records to identify errors and issues.

Faster Product Release Through Efficient Batch Record Review is a live training class. Upon course completion, students will be able to:

1. State the source of batch record requirements for both US and EU 
2. Distinguish between the production and QA batch record review 
3. List best practices in Batch Record Review 
4. Demonstrate at least 5 different batch record review activities

In-house projects will be used to demonstrate and practice the skills and principles of this class.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts website