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Knowledge Management Applied in Facilities & Engineering to Improve Manufacturing Reliability

Apr 06 - Apr 07, 2017
Anaheim, CA

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

Overview

This course will engage participants in a common goal of effecting positive change and improving equipment, facility, and utility reliability through facilities and engineering. Participants will learn to identify and anticipate equipment problems, and then apply techniques to ensure resources are provided to those equipment issues. Topics and perspectives presented will aim to provoke thought and elicit potential actions that participants can take back to their organizations, such as analyzing and presenting the cost of quality and comparing the impact of fixing the problems now, fixing them later, or fixing when it's too late. Through the lens of facilities and engineering work, this course will traverse the FDA process validation lifecycle with a punch list of many topics, some of which are: aging facilities; knowledge management; and, meaningful metrics.

Who Should Attend

Professionals in the pharmaceutical industry who have the following roles and/or responsibilities will benefit from this course:

  • Engineering
  • Facilities
  • Maintenance
  • Project Management (i.e., new build/expansion)
  • Finance/Accounting
  • Learning & Development
  • Process Excellence
  • Manufacturing
  • Quality

Prerequisites

Prerequisites include expectations that participants have experience working in or working closely with Facilities & Engineering teams. Participants should have experience with some, but not all, of the following:

  • Working knowledge of equipment maintenance; equipment selection including documents URS, design qualification, commissioning, etc.
  • Experience with capital project requests
  • Familiarity with personnel qualification and training practices
  • Familiarity with departmental metrics and the data sources involved
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Agenda

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

    • Introduce Cost of Quality in Facilities & Engineering (F&E) to demonstrate long term value of resource investments
    • Classify Cost of Quality categories for association to F&E work at scrap, appraisal, and prevention costs
    • Illustrate a Cost of Quality analysis to teach important attributes of a successful capital project proposal
    • Examine current ways issues are identified in equipment/facilities/utilities and evaluate their effectiveness
    • Collaborate and assemble an improved way to track and trend issues to feed Cost of Quality analyses
    • Construct vision and mission statements that could be shared among F&E professionals
    • Identify knowledge gaps within F&E teams and knowledge gaps outside of F&E groups
    • Develop a keyword-based knowledge transfer solution that fills gaps within and outside of F&E groups

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    More information coming soon.

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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.

Anaheim Marriott

700 West Convention Way
Anaheim, CA

Chris M. Hanff, CMQ/OE, Senior Consultant and Project Lead, CONCORDIA ValSource, LLC

Chris Hanff has over 16 years’ experience in biopharmaceutical operations, quality systems, and has worked on a number of projects ranging from suite start-up and design-construction / commercialization efforts to pharmaceutical manufacturing management. He has extensive experience in essential quality management systems oversight, design, and remediation, including under FDA sanctioned consent decree.

Chris consults for the pharmaceutical industry related to quality risk management, quality systems development and deployment, lean manufacturing, value stream mapping, metrics development, statistical analyses, compliance, TrackWise, DocCompliance and similar enterprise software solutions, aseptic processing, and manufacture. He has a wide range of product experience including biotechnology, sterile product, injectables, lyophilization, medical device, and active pharmaceutical ingredients (API).

Chris has significant depth and breadth of experience as an architect of Quality Systems including: Management Review; Quality Risk Management (QRM); CAPA; Investigations; Complaints; Annual Product Review; Metrics & Trending; TrackWise EQMS; FDA mandated Consent Decree Remediation; Cost of Quality.

How to Get Here

By Air

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By Car

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Other Options

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Directions

Registration Fees

Regular Price

Standard

Member

On or before February 20, 2017
$1,709

After February 20, 2017
$1,899

Nonmember

On or before February 20, 2017
$2,051

After February 20, 2017
$2,279

Government/Health Authority/Academic

Member

$1,139

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by March 7, 2017, 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 [email protected] or +1 (301) 656-5900.

Class Schedule

All lab courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your 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.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

This course will take place at:

Anaheim Marriott
700 West Convention Way
Anaheim, CA 92802
Phone: +1 (714) 622-3056

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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