Vivian B in action

Training Course Development & Support

I’m so glad you landed here! Sounds like you need training to be developed and /or delivered. I can help navigate your next steps. Let’s begin the virtual tour, shall we?

Your goal is to do what?

GMP Basics options

GMP Basics for New Hires | Lessons include:

History of GMPS, GMP Workstyle, Controlled Documents with emphasis on Good Documentation Practices | More Information

GMP 101 – Back to Basics for Employees | Lessons include:

Abbreviated History, Written Procedures, GMP Workstyle, Housekeeping, Validation Essentials, Inspections & Audits | More Information

7 GMP Work Habits – Course 1 | More Information

Complying with our GMP Work Habits – Course 2 | Lessons include:

Quick Refresh of GMP Workhabits, Good State of Repair, GDP’s Activity, Quality Records | More Information

What’s the Goal?

Refresher topics

Note: Any of the GMP Messages above can be used for a refresher requirement provided that current examples are provided to meet the “c” in CGMP.

Good Doc Principles Course 1Where Did All the Rules Come From? | More Information

Good Documentation Principles Course 2 Meeting Expectations for Controlled Documents | More Information

GMP Messages for
  • History of GMPs
  • Establishing GMP Work Lifestyle
  • Following Written Procedures
  • Batch Records – Lab Records
  • Facilities and Housekeeping
  • Validation Essentials
  • 3 Cross Functional Systems: Change Control, Deviation/CAPA, Training
  • More Information

Topic selection can be the biggest hurdle for compliance trainers. Very often, the design is put to the side while other more pressing priorities are at the top of the list. Don’t let that happen with your next refresher.

I work with compliance trainers to get their designs started. The first brain-sparking conversation is gratis. And that’s usually all it takes. For others, like those that are just starting out on their design journey or quality professionals who suddenly are assigned the GXP Refresher in their inbox, there is support available.

What’s the Goal?

Topic Specific

-You want a specific topic developed. Great! Next Step is to have a conversation with Vivian Bringslimark.

-You need support to design and develop a training workshop for a targeted process, system redesign, or new software implementation. The next step is to have a conversation with Vivian Bringslimark.

GXP Intermediate Training

GMP Audit Teams

Transferring GMPs Back to My Workspace

More Information

What’s the Goal?

Quality Systems Intermediate Curriculum
  • Beyond GXPs: State of Control
  • Approx. 2 – 3 hour hands-on workshop for QA staff, first-line supervisors, and site leadership.
  • Not recommended for a site-wide audience.
  • Strategies for examining the current state of selected quality systems. Highly interactive and utilizes intact workgroups from designated departments, functional groups a/o quality systems.
  • More Information
  • Operator Error: Is Retraining the Right Corrective Action? – Course 1
  • Approx. 75 – 90 minute course intended for employees who are required to investigate human error deviations.
  • Not recommended for site wide audience, ideal for QA /QS staff.
  • More Information
  • Understanding Human Error/Operator Error Root Causes – Course 2
  • A 2- 3 hour course intended for employees who are required to investigate HE/OE deviations.
  • Not recommended for site wide audience, ideal for QA /QS staff.
  • Can be applied for clients who offer GXP choice for second /third refresher requirement.
  • More Information
  • Understanding Human Factors to Prevent Operator Errors – Course 3
  • Approx. 6 hour course intended for employees who are required to investigate human error deviations and write corrective actions. This course includes content from Understanding HE/OE root causes.
  • Ideal for QA /QS staff, supervisory, leadership and Subject Matter Experts.
  • More Information

Problem Solving Workshop

Internal Auditors Workshop

More Information

What’s the Goal?

Remediation – CAPA Corrective Action

What commitments were given to the Agency?

BACK -TO-BASICS / re-educate our employees |Consider GMP 101 Curriculum

Enhance OJT Program | More Information| Contact Vivian

Create a GxP Training Plan | Establish a Process for GMP Training Course Development | Contact Vivian

Client Specific Response |Training Related CAPAs

What’s the Goal?

-Have you heard of Rapid Design sessions? For clients who are serious about changing their GXP culture. More Information

What’s the Goal?

Prepare employees for pending inspection
  • What type of inspection are you anticipating?
  • Pre-Approval Inspection
  • Routine Inspection
  • Post Inspection Follow Up
  • Other

Inspection Preparation and Readiness Curriculum | Courses and coaching for preparation, coordination, and responsibilities pertaining to regulatory inspections.

More Information Please | Contact Vivian

What’s the Goal?

Training – Qualifying subject matter experts

HPISC Qualified Trainers Workshop | SMES as Department Trainers

HPISC Intermediate Curriculum for QTs | Rewarding Your QT Rock Stars

Qualifying Deviation Investigators

What SMEs Need to Know About Course Design | HPISC Boot Camp for Technical SMEs

Designing GXP Refreshers | HPISC Coaching Program for Compliance Trainers

More Information

Meet your Instructional Designer, Vivian Bringslimark
Hey, I get it.

Meeting compliance training requirements is overwhelming. There are numerous paths you can take. Right now, you are probably more focused on making the right choice. I can help you decipher all the noise and suggest the next steps, even if it means choosing another instructional designer.

Let’s strategize together. The discussion is gratis.

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