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Establishing and Implementing an Effective GMP Auditing Program

Jul 22, 2020
Bethesda, MD

  • Education
  • The Americas
Cancelled

Overview

The role of the GMP auditor can be one of the most challenging ones in the pharmaceutical, biopharmaceutical and medical device industries. Performing an independent assessment of operations, identifying areas of potential concern, and ensuring appropriate and effective corrective actions are taken is critical to ensuring firms maintain a solid compliance posture and that management is aware of any potential compliance concerns.

This training course is designed to give participants an understanding of the value in identifying the perils and pitfalls in establishing and running an effective GMP audit program and ways to overcome them. The unique challenges associated with supply chain auditing will also be addressed. The training course will be interactive, using a combination of lecture, case studies and small group discussions. Participants will develop an audit plan and supporting documentation during the session. Attendees will prepare an audit report using examples of actual audit findings provided by the trainer.

At the conclusion of the training course, participants will have a better understanding and awareness of why an audit program is necessary, how it should be constructed, operated and maintained, as well as an appreciation for the most effective ways to communicate and follow up on audit findings.

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Robert L. Dana
Robert L. Dana
Elkhorn Associates Inc.
Bio
Robert L. Dana
Elkhorn Associates Inc.

Robert Dana is the President of Elkhorn Associates Inc., a firm providing quality and regulatory compliance consulting services to the health care industry. He has been associated with the pharmaceutical industry for over 50 years. He joined Bristol Laboratories in 1967 as a Research Scientist and was subsequently named Manager, Product Development for their Animal Health Care Products Division.

He joined the Bristol Myers Squibb Corporate Staff in 1984 as a GMP auditor and progressed through a series of responsibilities, retiring from BMS as Senior Director, Corporate Compliance Assurance; where he led a department responsible for providing GCP, GLP, GMP, Animal Welfare and Controlled Substance auditing and compliance support services to BMS operations worldwide.

He joined the staff of PDA as Vice President, Quality and Regulatory Affairs in 2005, was named Senior Vice President, Regulatory Affairs and Training and Research Institute in 2009 and Senior Vice President, Education in 2013. He retired from PDA in December 2015.

Mr. Dana holds a B.S. degree (Pharmacy) from the University of Connecticut. He is a former Director of PDA and the University of Connecticut Pharmacy School Alumni Association and is currently an emeritus member of the University of Connecticut Pharmacy School Advisory Board.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify common perceptions and misperceptions associated with GMP auditing and how to address them
    2. Develop effective audit plans and prepare and use documentation to support the audit process
    3. Identify different types of audits and determine where and when to use them
    4. Prepare and deliver effective audit reports to appropriate levels of management and conduct effective follow up
    5. Examine the unique challenges associated with supply chain auditing and develop strategies to address them
  • Who Should Attend

    This training course is intended for professionals who are involved in GMP auditing.

    Departments
    Quality Assurance, Quality Systems, Quality Compliance, Regulatory Affairs, Supply Chain

    Roles
    Auditor, Consultant, Director, Manager, Pharmacist, Supervisor

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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.

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Registration Fees

Early Registration
Registration Type Price By June 5, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979
Regular Registration
Registration Type Price After June 5, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* 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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