$2,195

5-Day • ISO 15378:2017 Primary Packaging Materials for Medicinal Products

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Location

Hilton Garden Inn Valley Forge/Oaks

500 Cresson Boulevard

Phoenixville, PA 19460

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Refund Policy

Refund Policy

Refunds up to 7 days before event

Eventbrite's fee is nonrefundable.

Event description

Description

This is an ISO 15378:2017 Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO 9001:2015, with Reference to Good Manufacturing Practice (GMP) LEAD AUDITOR Exemplar Global Certified Course

Litts Quality Technologies, Inc. will be conducting this 5-day class in the Philadelphia suburbs near Valley Forge National Historical Park.

SESSION DATES

This is a 5-day class.

8:00am – 5:30pm • Monday, March 9th
8:00am – 5:30pm • Tuesday
8:00am – 5:30pm • Wednesday
8:00am – 5:30pm • Thursday
8:00am – 12:00pm • Friday, March 13th

Light snacks and lunch provided.
When you register, please provide information related to any special dietary needs, allergies, etc.

Special Needs:

We are happy to accommodate reasonable accessibility needs, including but not limited to dietary restrictions or physical assistance. Please e-mail us at info@littsquality.com to let us know how we can assist you.


Who Should Attend:

  • Management Representatives

  • Quality Managers

  • Internal Auditors

  • Potential Internal Auditors

  • Auditors who want to start the process of becoming Third-Party Auditors

  • Purchasing employees

  • Any management team member of an organization that is registered to or wants to become registered to ISO 15378:2017 to gain an understanding of the requirement.

Please register on-line here, or email rick@littsquality.com, or call 1-877-LQT-6001 {1-877-578-6001}.

If you have any questions regarding this information please feel free to contact us.


COURSE OBJECTIVE

The major objective of this course is to provide knowledge in the method of Leading Quality Management System (QMS) audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process

The attendees will be able to function as Lead internal (First Party), interested party (Second Party) and Certification Body (Third Party) audits.

Exercises and quizzes are used to help with the understanding of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:

Attendees will Receive from Exemplar Global

  • 12 months of ongoing professional development and support through direct access to a series of tailored learning content

  • Exemplar Global Graduate personnel certification to enhance their employment potential

  • Access to complete the Work Style Assessment self-coaching tool

  • Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing

  • Continuing professional development opportunities through access to webinars, online articles, and events

  • Greater support on their career path


COURSE OUTLINE

DAY 1

  • Introductions

  • Course Objectives and Requirements

  • An overview of Exemplar Global

  • The Strategic Direction and Context of an organization

  • The Concepts and Language used in the Standards

  • The goals and objectives of the ISO 9001:2015, ISO 9000:2015 and ISO 9004:2018 Family of Standards

  • Interaction of the ISO 900X:20XX QMS Standards with the ISO 15378:2017 Primary Packaging Materials for Medicinal Products

  • Concepts and language

  • Definitions

  • The 7 Quality Management Principles used in the development of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard

  • Detailed review of ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard

DAY 2

  • Quiz

  • Continuing review of the detailed requirements of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard

  • The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems

  • The terms and definitions used in auditing

  • The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems

    - Step 1 - Initiating the Audit

    - Step 2 – Preparing Audit Activities

    - Step 3 - Conducting Audit Activities

    - Step 4 - Preparing, approving and distributing audit report

    - Step 5 - Completing Audit

    - Step 6 - Conducting audit follow-up

  • Review of an Audit Procedure and related forms

DAY 3

  • Quiz

  • GMP’s

  • Attendees review a case study and prepare to perform Mock Process Audits

DAY 4

  • Quiz

  • Perform case study Mock Process Audits

  • Writing audit reports

  • Writing requests for corrective actions

DAY 5

  • Review

  • Complete the Exemplar Global Work Style Assessment self-coaching Tool

    (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)

  • Final Test

  • Course Evaluation

  • Final Test


COURSE MATERIALS

Litts Quality Technologies, Inc. will provide a:

  • Student Workbooks

  • Certificates


PREREQUISITES

Attendees are required to obtain a copy of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.

LQT Inc. will have several loaner copies of the ISO 15378:2017 Primary Packaging Materials for Medicinal Products Standard and ISO 19011:2018 standard available that may be shared with other attendees, during the course. These loaned copies cannot be marked-up during use.


COURSE REQUIREMENTS

  • Attendance is important – monitored

  • A final test is administered at the end of the training session to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.

  • The final test is two part and attendees will have two (2) hour to complete it (Note: Anyone with special needs will be allowed and extra fifteen (15) minutes:

    • Part 1 - Multiple Choice Closed Book | Part 2 Written Open Book

    • To receive a “Successfully Completed Certificate” with the Exemplar Global Logo, an attendee must obtain a score of > 70% on the final test

    • If > 70% is not achieved on the final test, then an attendee will receive an “Attended Certificate” without the Exemplar Global Logo

    • If you receive an “Attended Certificate” you can take a retest within 6 months of the last day of the class and if you score > 70% you will receive a “Successfully Completed Certificate”


COST OF THE PROGRAM

$2,195.00 per attendee.

A 5% discount is offered for 3 or more attendees from the same organization registered at the same time.

Seating is limited so register early.

PAYMENT TERMS

Credit Card Payment or Check (received prior to the first day of the training class) are accepted.


CANCELLATION POLICY

All cancellations must be received by March 2, 2020. After that date, any payments cannot be refunded. However, alternate attendee(s) may take the course in place of the person(s) who originally enrolled.

Litts Quality Technologies, Inc. reserves the right to cancel the training program should sufficient enrollment not be achieved by the cut-off date and shall not be responsible for any attendee costs associated with cancelled transportation or accommodation reservations.

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Date and Time

Location

Hilton Garden Inn Valley Forge/Oaks

500 Cresson Boulevard

Phoenixville, PA 19460

View Map

Refund Policy

Refunds up to 7 days before event

Eventbrite's fee is nonrefundable.

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