Learning, Knowledge Management and Impact: Moving from Theory to Practice Training Course
Registration Options
Individual Registration
Group Registration
The ICH Q10 Pharmaceutical Quality Systems document, FDA, other national authorities, and industry experts identified that knowledge management is an enabler – a foundation – to a modern pharmaceutical quality system. The current practices of training across the industry are limited in how they contribute to knowledge management. As a result, a growing number of firms and organizations are changing their focus from “training” to looking at “learning” as a way of sharing knowledge and developing their people. Changing this point of view is more than just words – it must involve a change in perspective of doing things differently. This movement, from training to learning, comes at the same time when our industry is trying to better understand knowledge management and how this contributes to process understanding, human performance, and product quality.
In this training course, key theories that describe knowledge management and how people learn will be examined. Using these theories, participants will find ways to apply them to some of the practical challenges faced in the pharmaceutical/biopharmaceutical industry, such as knowledge acquisition and transfer, procedure writing and training, new employee on-boarding, web-based learning, and assessment and evaluation. A large portion of this training course will involve identifying best practices, both inside the industry and beyond, and using this information, along with the group’s experience and creativity, to reimagine what can be done differently.
Upon completion of this training course, the attendee will be able to:
- Describe four learning theories and their practical implications
- Identify regulatory expectations for training and performance
- Describe knowledge management, emphasizing the roles of individual and organizational learning
- Develop alternative approaches to knowledge transfer that are grounded in good learning practices and meet regulatory expectations
- Discuss different models for assessing and evaluating learning and learning programs
- Identify ways that learning and impact can be evaluated given alternative approaches for learning
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Standard Registration
Member Price
$1,999GovernmentMember Only
$1,399
Health AuthorityMember Only
$1,399
AcademicMember Only
$1,399
Non-Member
$2,399
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 registration@pda.org.
Featured Trainers
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Martin J. Lipa, PhD
Lipa Group LLC
Read BioMartin J. Lipa, PhD
Lipa Group LLC
Martin (Marty) Lipa has over 25 years of biopharmaceutical industry experience, including over a decade in Knowledge Management (KM). Currently, Marty is a principal consultant at Lipa Group LLC as well as a Senior Research Fellow with the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin. Most recently, Marty was Executive Director at Merck & Co. where he founded Merck’s KM strategy and delivered significant value enhancing operational efficiency, quality and talent development. His prior experience includes various roles in technology, engineering, operations, digital, and validation. Marty has a PhD in Pharmaceutical Sciences, a Lean Six Sigma Black Belt and is a globally recognized thought leader in innovative and pragmatic KM practices. He is an active member of the global KM community as a regular speaker, author, and volunteer, and has been recognized for his industry contributions by ISPE as the Max Seals Yonker Member of the Year.
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James L. Vesper, PhD, MPH
Director, Learning Solutions, ValSource, Inc.
Read BioJames L. Vesper, PhD, MPH
ValSource, Inc.
James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Beginning in March 2017, he became Director, ValSource Learning Solutions after establishing and being president of the firm, LearningPlus, Inc. At ValSource, he leads a business unit that provides innovative learning solutions to pharma firms world-wide, leveraging the capabilities and expertise of ValSource consultants. He has had more than 35 years experience in the pharmaceutical industry.
Dr. Vesper has written six books, including Root Cause Investigations for CAPA
(2020) and multiple technical articles. His 5thEdition of GMP in Practice, written with Tim
Sandle published in 2016 by PDA/DHI. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has been a mentor on six of the WHO’s unique learning program, Pharmaceutical Cold Chain Management on Wheels. He has trained health authority inspectors through WHO and PIC/S in US, Brazil, Taiwan, London, China, Greece, and Turkey.
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Request InformationPLEASE 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.
PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD 20814, USA
Accommodations
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814