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PUBLIC TRAINING

SAN DIEGO

San Diego is home to more than 1,100 different life science organizations! Come see the sun, the sand, and then engage in Quality System Training for you and your team!

Quality System Regulation (QSR)

August 12, 2019

  • Identify general compliance expectations.
  • Identify the key elements of the QSR.
  • Hands-on activities to apply to your quality system.
  • Fulfill new hire and annual FDA training requirements.

Current Good Manufacturing Practices (cGMP)

August 12, 2019

  • Explain and define GMP and cGMP.
  • Discuss the role of the FDA in the cGMP process.
  • Describe the types of inspections and potential outcomes for cGMP.
  • Fulfill new hire and annual FDA training requirements.

Root Cause Investigations

August 13, 2019

  • Reduce repeat investigations.
  • Conduct root cause analysis.
  • Shorten investigation cycle time.
  • Use quality tools, 5 Whys, Fishbone, IS/ IS NOT.

Technical Writing Principles

August 14, 2019

  • Decrease the number of revision required.
  • Have inspection ready documents.
  • Identify regulatory expectation for technical writing.
  • Clarify principles and techniques for technical writing.

FAILURE MODES AND EFFECTS ANALYSIS (FMEA)

August 15, 2019

  • Apply critical thinking to processes and systems.
  • Approach risk in a proactive manner
  • Create a working FMEA document to support QRM methodology

HUMAN FACTORING RECORDS

August 16, 2019

  • Define human factoring terminology.

  • Examine how document design affects human performance.

  • Review documents for human factoring opportunities.

Investigations and CAPA

December 3-4, 2019

  • Reduce repeat investigations.
  • Conduct root cause analysis.
  • Shorten investigation cycle time.
  • Identify the most effective actions.

Technical Writing & Documenting Investigations

December 5-6, 2019

  • Decrease the number of revisions required
  • Create inspection ready documents 
  • Document expectations will be aligned across the organization
  • Clearly identify the problem, cause(s), and action(s)

ONE DAY COURSE PRICING

One course………….. $795

Two courses………….$1,095

Three courses……….$1,695

Four Courses…………$1,999

TWO DAY COURSE PRICING

One course………….. $1,395

Two courses………….$1,999

Pricing includes course materials and lunch each day of the event.

(Early Registration available for individual courses! No code required! Click on registration link for current early bird pricing!)

Group rates available!  CONTACT US for details!

Boston, Massachusets

Host Site: 
New England Donor Services

60 First Ave. 

Waltham, MA

Suggested attendees for Writing Standard Operating Procedures (SOPS) training are authors, batch record authors, reviews, and approvers. Our SOP writing course uses a blended approach of classroom and real-life work application. This approach allows participants to practice new tools and concludes with a review of an existing document to apply the learning.

With groups of 5+ it may be more cost effective to bring our PathWise trainer to your site.

Fill out the form below, and let us know your group size, location, and training needs. A PathWise representative will get back to you with information for an on-site training!

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View our other

Open Enrollment

locations for 2019

HERE!

ONE DAY COURSE PRICING

One course………….….. $795

Two courses………….$1,095

Three courses……….$1,695

Four Courses………..$1,999

Pricing includes course materials and lunch each day of the event.

(Early Registration available for individual courses! No code required! Click on registration link for current early bird pricing!)

Group rates available!  CONTACT US for details!

QUESTIONS ABOUT OUR PUBLIC TRAINING? INTERESTED IN GROUP PRICING?

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