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Quality Culture Assessment Tool and Training - November

Nov 06 - Nov 07, 2018
Santa Monica, CA

You will learn how to use the Quality Culture Assessment Tool to effectively collect verifiable data. As a result, the tool will allow you facilitate positive culture changes and continuous improvement within your organization.

  • Education
Program Highlights

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.

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

Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Overview

Regulators are increasingly focused on quality culture as they recognize its impact on the production of quality products.

Do you know how to measure quality culture at your manufacturing site and implement the necessary steps to improve it?

We can help!

PDA has developed the Quality Culture Assessment Tool and Training 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 40 sites from 24 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.

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!

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!

Help advance PDA's research on the links between improving Quality Culture and strengthening site operating results by also participating in the St. Gallen OPEX Survey or Operational Excellence and Quality Metrics Conference, the next of which takes place Oct. 30 in Berlin, Germany. Participants in both programs will receive a combined analysis of PDA's Quality Culture and OPEX scores. To learn more and register, please visit http://tectem.ch/institute/opex/conference.

Who Should Attend

This program will benefit pharmaceutical and biopharmaceutical manufacturing leaders who want to measure quality culture maturity at their plant sites and identify areas for improvement. This program will also prepare assessors to conduct site evaluations in a consistent and verifiable manner using the PDA Model and Tools.

Agenda

  • Upon completion of this program, you will be able to:

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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • 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:
    Type of Activity: Not Applicable

    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 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 PDH credits.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Kite Pharma

2400 Broadway
Santa Monica, CA

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Member

$3,999

Nonmember

$4,999

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by October 8, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

Kite Pharma
2400 Broadway
Santa Monica, CA 90404
USA

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

* 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 registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

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

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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