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The Common Sense of Quality Auditing

Aug 12, 2019
Bethesda, MD

  • Education
  • Western Hemisphere Events
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Overview

DATE CHANGE
Please be advised that training course 527 The Common Sense of Quality Auditing has been rescheduled to Aug 12.

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 training course journeys through the adventures of an audit and will tour three themes: communication, preparation and credibility.

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Agenda

  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

Trainers

Kerry Potter
Kerry Potter
Summit Consulting, Inc.
Bio
Kerry Potter
Summit Consulting, Inc.

Kerry Potter gained his pharmaceutical manufacturing (API and Finished) experience during his 28-year career with Merck in Elkton, Virginia. Kerry’s career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included project manager of laboratory assessment, FDA Quality Management System implementation, and GMP training (annual, ongoing, new hire); administrator of site quality performance, OSHA regulations and Process Safety Management training, as well as internal and external public relations.

He has received qualifications and certifications in the areas of facilitation and training, including instructional design and competency-based curricula. Kerry also received local and national awards for chapter management during his tenure as President of the Blue Ridge Section of the American Society for Quality Control, now the ASQ. Other current and past affiliations include Association for GXP Excellence, American Society for Training & Development, PDA, GMP-Training & Education Association, and Association for Quality & Participation. He is also a certified Pro-Trainer and facilitator, and an Advanced Toastmaster (www.toastmasters.org).

In 2006, Kerry founded Summit Consulting, Inc. in order to offer a combination of business and hands-on consultation, training and mentoring services for the pharmaceutical manufacturing industry. This combination is founded on the areas of project management of regulatory compliance and quality systems; quality assurance; quality systems audits; change control; laboratory testing; design and presentation of regulatory training; employee development; GMP and documentation; and regulatory agency interaction and communication. Kerry serves as the principal consultant of Summit and is currently supporting clients with Quality Systems remediation efforts, and GMP mentoring for pharmaceutical and API manufacturing. He also facilitates public and private on-site training seminars on regulatory compliance topics, both domestically and in Europe.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the impact of proper auditee notification
    2. Describe the best characteristics of and assemble an Audit Team
    3. Define pre-audit activities for your team and area
    4. Determine auditing strategies
    5. Evaluate skills and characteristics of a quality auditor
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved with internal audits.

    Departments
    Quality Assurance, Manufacturing, Quality Control, Regulatory Affairs

    Roles
    Auditor, Auditee, Specialist, Analyst, Supervisor, Manager, Director

  • Accreditation

    Accreditation

    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 # / ACPE # / CEUs: 527 / 0116-0000-16-045-L04-P/ 0.6
    Type of Activity: Application

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    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 (PDH) 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 PDH credits.

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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.

Directions

Registration Fees

Early Registration
Registration Type Price By June 28, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839





Regular Registration
Registration Type Price After June 28, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839





* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Jul 13, 2019, no fee will be charged. After Jul 13, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Jul 13, 2019, a full refund will be given minus a $200 fee. After Jul 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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