Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader - in-Pharma Technologist

• People also search for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
  

Read the full article: Calling all QA/QC whizzes: US FDA 'super' office hunts quality leader - in-Pharma Technologist:

"Last week Janet Woodcock – Director of the Center for Drug Evaluation and Research (CDER) – sent a memo announcing the agency had begun recruiting for the permanent Director of the new “super office,” calling for those looking to lead the CDER in matters related to the regulation of pharmaceutical quality to apply before April 14."

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Advanced GMP Training - The Qualstar Pharma Simulation

QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

This cGMP training course excites, energizes, & engages students! --- Topics cover documentation, following procedures, change control, deviations, & more.

Do you have problems with documentation, following procedures, change control or deviations?

If you said, "Yes," then read on ...  Employees work in small teams in this unforgettable 3-4-hour industry simulation. The importance of documentation, procedures, change controls and deviations are stressed through competition, citations, fines, injunctions, and in some cases, even jail terms. A very short lecture component is customized to address your site’s specific compliance needs.

Learn more:  QUALSTAR - PHARMACEUTICAL SIMULATION (GMP TRAINING)

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Top 10 U.S. Biopharma Clusters - GEN

View the complete list: GEN | Insight & Intelligence™:Top 10 U.S. Biopharma Clusters:

"GEN ranks regions based on five criteria:  . . .

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1. NIH funding
2. Venture Capital (VC) funding
3. Patents
4. Lab space
5. Jobs

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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

• People also look for FDA GMP Online Training - respected FDA CGMP online training courses offered by SkillsPlus International Inc.

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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Advanced GMP Training For Leaders - The Executive Session

Updated April 22, 2024

Our Executive Session course is no longer offered.

You might also be interested in:

• FDA cGMP QSR GMP Training Courses by SkillsPlus International Inc.

---  the original post follows below  ---

Executive Session - Advanced cGMP Training

"Executive Session" is an advanced cGMP training course that addresses CGMP & QSR issues directly relevant to the executive leadership and management teams of manufacturers.

It can be hard to get busy executives into GMP training, even with the FDA citing companies for their executive team’s lack of CGMP training.

• This course is designed to meet their busy schedule. 
• Lasting 1-4 hours, this onsite class reviews current citation trends and compliance issues important to the busy executive. 
• This course is completely customized for your company. 

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Recommendations for 2014 GMP Training - Executive Session: What Leadership Needs to Know

 

483 Observation Gotchas!

 

1. Firm lacked an effective training program to ensure all employees, including upper management, are fully trained on CGMPs.

2. Management failed to prevent non-controlled documents from being in the dispensing area.

3. Management did not understand their role & responsibility in supporting & enforcing the quality system.   

 

 

Planning for Training 2014!

 2014 is just around the corner! 

1. Can't get management staff to attend your CGMP training sessions, or
2. Not quite sure what to present to management staff for annual CGMP training, or
3. Does management feel that they do not need to attend annual CGMP training?

If you answered "Yes" to one or more of these questions, then you need to take a look at our Executive Session 2014 CGMP Update.

Learn More About the SkillsPlus Executive Session 2014 CGMP Update Course

  

 

Featured Course

Executive Session 2014 CGMP Update: This course focuses on what the executive needs to know. There's no discussion of "single-line through ... yada, yada, yada," in this course.

 

Topics addressed in this intense update:

1. Annual observation update

2. What the observations mean to executives and managers

3. Consequences

4. Interesting court cases

5. Current trends and more!

 

If your firm needs to get some of your executives and managers into meaningful CGMP training, then you need to look into our Executive Session 2014 CGMP Update!

Examine The Executive Session Outline

 

Allan Dewes, President.

 

About Your Instructor

Allan Dewes

Allan Dewes has been training CGMP for over 30 years, including managers and executives. Allan knows how to adjust his comments and focus on the needs of executives and managers.

Email today to request a quotation

 

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