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Parenteral Drug Association Connecting People, Science and Regulation ®

The Common Sense of Quality Auditing

Jun 25 - Jun 25, 2018 |
Jun 25, 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 days of the stern-faced auditor conducting an intense audit and creating a stressed-out auditee are over…or should be! Common sense tells us that just as the pharmaceutical industry has changed, so must the audit. While the goal of the audit remains the same (i.e., a systematic and independent examination to determine whether quality and related activities within an organization demonstrate a state of control), its primary objective is to benefit the function being audited. The success of this objective is dependent on both the auditor and the auditee. This one-day course journeys through the adventures of an audit and will tour three themes: communication, preparation and credibility.

Who Should Attend

Individuals who are involved with internal audits, whether auditor or auditee, from quality assurance, quality control, manufacturing or other functional areas will benefit from this course.

Prerequisites

None; in fact, the less one knows the better so participants can start the auditing journey on the right footing and learn the proper auditing philosophy, tools and techniques.

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

  • Describe the impact of proper auditee notification
  • Identify verbal and non-verbal stages of the audit
  • Employ elements of a well-written audit report
  • Describe the best characteristics of and assemble an Audit Team
  • Define pre-audit activities for your team and area
  • Determine auditing strategies
  • Evaluate skills and characteristics of a quality auditor
  • Contrast “do’s and don't’s” of an audit
  • Develop and demonstrate auditor professionalism
  • Manage the audit

Standard

Member

On or before May 11, 2018
$1,192

May 11, 2018
$1,325

Nonmember

On or before May 11, 2018
$1,431

After May 11, 2018
$1,590

Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by May 28, 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 info@pda.org or +1 (301) 656-5900.

General Course Information

Please arrive at the 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.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
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

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

Kerry Potter, Quality Systems Trainer and Consultant, Summit Consulting, Inc.

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 #527 | ACPE #0116-0000-16-045-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.

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