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Parenteral Drug Association Connecting People, Science and Regulation ®

Establishing and Implementing an Effective GMP Auditing Program

May 03 - May 03, 2018 |
May 03, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

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 making sure that firms maintain a solid compliance posture and that management is aware of any potential compliance concerns.

This lecture-based 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 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. Students will prepare an audit report using examples of actual audit findings provided by the instructor.

At the conclusion of the 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.

Who Should Attend

Quality assurance directors and managers, GMP audit managers, GMP auditors, and regulatory compliance managers will benefit from this course.

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

  • Identify common perceptions and misperceptions associated with GMP auditing and how to address them
  • Develop effective audit plans and prepare and use documentation to support the audit process
  • Prepare and deliver effective audit reports to appropriate levels of management and conduct a follow-up



On or before March 19, 2018

After March 19, 2018


On or before March 19, 2018

After March 19, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by April 2, 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 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 110
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

Robert L. Dana, President, Elkhorn Associates

Mr. Dana is President of Elkhorn Associates Inc. He has been associated with the pharmaceutical industry for almost 50 years. After a brief employment as a community pharmacist, he joined Bristol Laboratories in 1967 as a Research Scientist in their Product Development Department, and was subsequently named Manager of Product Development for their Animal Health Care Products Division. His responsibilities included dosage form development, preparation of clinical trial materials, oversight of third party manufacturing operations and preparation of the CMC sections for Investigational New Animal Drug and New Animal Drug Applications. He joined the Corporate Staff of Bristol-Myers Squibb in 1984 as a GMP auditor and progressed through a series of additional responsibilities, retiring from BMS (BMS) in 2001 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 then formed Elkhorn Associates Inc., a private firm providing consulting services to the Health Care industry in the areas of Quality and Regulatory Compliance. He joined the staff of the Parenteral Drug Association (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 after 10 ½ years of service in December 2015.

He has spoken on Quality and Compliance issues at various conferences globally, has been a lecturer at the University of Tennessee’s Continuing Education course on aseptic processing and serves on the faculty for PDA where he lectures on Quality and Regulatory topics for several PDA courses.

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

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 #113 | ACPE #0116-0000-15-023-L04-P | 0.6 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 6 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 6 PDHs.