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We also recommend: [Executive Session: What Leadership Needs to Know] [Management Session: What Every Manager Needs to Know] [Surviving an FDA Inspection] [Creating CGMP and QSR Responsibility and Accountability]


Meetings for Swift and Aggressive Regulatory Enforcement




In the current regulatory environment of "swift and aggressive" enforcement, organizations must respond quickly with well-thought-through plans. In this class, learn to manage meetings efficiently using many common regulatory tools such as; brainstorming, consensus, root cause analysis, FMEA, decision matrix and other tools.



1.   Conduct an effective and efficient meeting.

2.   Conduct a stakeholder analysis

3.   State the rules for an effective meeting.

4.   Build meeting agendas that make the best use of everyone's time.

5.   Demonstrate effective meeting facilitation skills.

6.   Demonstrate consensus building skills.

7.   Practice the true art of brainstorming.

8.   Conduct a root cause analysis.

9.   Conduct a Failure Mode and Effects Analysis (FMEA).

10. Make a decision using a decision matrix.

11. Other tools that may be included or substituted can include; Walk Through Analysis and Control Barrier Analysis.

12. Identify the essential components of effective meeting minutes.

13. Develop effective follow up plans and agreements.

14. Manage disruptive meeting participants.


About the Class

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

  2. The optional final exam is approximately 25 questions.

  3. Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.

  4. This class can accommodate up to 25 people.

  5. Duration: 8 hours as a minimum. Depending on the project selected, this class may take several days.




1.     Meeting agenda

2.     Ground rules for the class

3.     An overview of a meeting


Meeting Fundamentals

1.     Ground rules: Definitions and how to agree to them

2.     Planning a meeting


Building an Agenda

1.     Meeting "desired outcomes"

2.     Planning for meeting tools to be used

3.     Stakeholder analysis

4.     An effective meeting invitation


Effective Meeting Tools



1.     Consensus defined

2.     Activity: Building consensus



1.     Brainstorming defined

2.     Ground rules for brainstorming

3.     Why those rules exist


Conducting a Root Cause Analysis

1.     Building the chart

2.     How to select the categories

3.     Conducting a Plus/Delta on the root cause brainstorming




1.     An overview of the process

2.     Activity: Conducting A Simple FMEA


Decision Making

1.     Decision making alternatives: Pros and cons

2.     The decision making matrix

3.     Activity: Making A Simple Decision


Other Tools Available

1.     Walk Through Analysis

2.     Control Barrier Analysis


Wrapping Up The Meeting


Meeting Minutes

1.     What to include

2.     What to exclude


Follow Up Plans

1.     What to include

2.     What to exclude


Managing Disruptive Meeting Participants

1.     Preventing disruptive behaviors

2.     Interventions to disruptive behaviors


Meeting Practice Sessions


Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.


For a prompt reply to requests and questions:  415.948.5220 |    |   Fax: 954.566.5225

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