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Quality Culture Assessment Tool and Training - Option 2

Sep 19 - Sep 20, 2019
Bethesda, MD

  • Education
  • The Americas

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Overview

The U.S. FDA continues to focus on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation. In a recently published document, FDA has called for routine assessment and management oversight of quality culture.

Make sure your company stays ahead of the curve! Prepare for this reporting on quality culture with PDA’s comprehensive Quality Culture Assessment Tool and Training, designed to guide your company to a better understanding of quality culture, how to assess it, and what actions to take to improve it.

Before you can implement this tool at your organization, you will be provided with the required comprehensive training. Over two days, you will learn how to use this tool to effectively collect verifiable data. As a result, the tool will allow you facilitate positive culture changes and continuous improvement within your organization.

The goal is to ensure that a quality mindset and behaviors are embedded into the daily work of the individuals involved in all functions to ultimately ensure the delivery of high-quality product to patients.

Gain hands-on experience with the Quality Culture Assessment Tool and Training that will enable you to collect vital feedback in the following areas:

  • Employee Ownership and Engagement
  • Continuous Improvement
  • Technical Excellence
  • Leadership Commitment
  • Communication and Collaboration

And there’s more! Enhance the value of your results with two complimentary resources provided exclusively to organizations who have participated in the assessment tool training:

  • Quality Culture Survey
    PDA will send an anonymous quality culture survey for all staff at your site to complete, after which PDA will collect and compile the results. This data will enable your site leadership to:
    • Gauge employee views on quality culture
    • Have a better understanding of where to tack action, how to track progress, and which decisions to make to improve the site culture
  • Benchmarking Data
    Your site will be provided with exclusive access to the consolidated, blinded results of more than 50 sites from 30 companies in North America, Europe, and Asia that have already completed the quality culture assessment. Use this data to compare the quality culture at your site against that of these other organizations.

To date, more than 100 regulators have been trained on the application of this tool to the pharmaceutical manufacturing industry.

Take the first steps toward evaluating the quality culture at your site and identifying opportunities for improvement by enrolling in the Quality Culture Assessment Tool and Training. The quality of your product and the safety of patients depends on it!

Agenda

  • Training courses run from 8:30 to 16:00 each day. An agenda will be provided on the first day of the training course.

Trainers

Denyse Baker
Denyse Baker
AstraZeneca
Chuck Bornhoeft
Chuck Bornhoeft
Upsher-Smith Laboratories, LLC
Steven R. Mendivil
Steven R. Mendivil
Independent Consultant
Susan Schniepp
Susan Schniepp
Regulatory Compliance Associates Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Use the Quality Culture Assessment Tool to identify strengths and opportunities for improvements across five key dimensions of quality culture
    2. Examine evidence to consistently assess culture metrics in a wide variety of manufacturing settings
    3. Use verifiable evidence to determine your company’s culture score
    4. Explain the importance of strong quality culture in a manufacturing operation
    5. Support leadership to engage site personnel in improving quality culture
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who want to measure and assess their company’s quality culture.

    Departments
    Quality Assurance, Manufacturing, Quality Control, Packaging, Regulatory Affairs

    Roles
    Supervisor, Manager, Director

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs: 538 / 0116-0000-18-019-L04-P / 1.2
    Type of Activity: Application

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is 12 CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is 12 PDH credits.

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By August 5, 2019
Member $2,429
Non-member $2,915
Gov't/Health Auth./Academic* $1,619








Regular Registration
Registration Type Price After August 5, 2019
Member $2,699
Non-member $3,239
Gov't/Health Auth./Academic* $1,619








* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Aug 20, 2019, no fee will be charged. After Aug 20, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Aug 20, 2019, a full refund will be given minus a $200 fee. After Aug 20, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
[email protected]

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