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Parenteral Drug Association Connecting People, Science and Regulation ®

Knowledge Management Applied in Facilities & Engineering to Improve Manufacturing Reliability

Nov 14 - Nov 15, 2017 |
Nov 15, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

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 such as aging facilities, knowledge management and meaningful metrics.

Who Should Attend

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

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


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

  • Working knowledge of equipment maintenance and 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

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 that issues are identified in equipment, facilities and utilities, and evaluate their effectiveness
  • Collaborate and assemble an improved way to track and trend issues to feed Cost of Quality analyses (as above)
  • Construct vision and mission statements that could be shared and common across 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



On or before October 2, 2017

After October 2, 2017


On or before October 2, 2017

After October 2, 2017

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by October 16, 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 or +1 (301) 656-5900.

Class Schedule

All lecture 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.


The course will be held at:

PDA Training and Research Institute
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

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.

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 #513 | ACPE #0116-0000-16-005-L04-P | 1.2 CEUs
Type of Activity: Application

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 (PDHs) 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 PDHs.