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Parenteral Drug Association Connecting People, Science and Regulation ®

Change Management – A Practical Workshop

Mar 15 - Mar 15, 2019 |
Mar 15, 2019 |
Marriott Marquis San Diego | San Diego, CA
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

This course is intended to highlight the need for a proper change management program that encompasses all GMP or application related changes and provides insight to the necessary involvement of various disciplines within the company. The course will be in three parts: one part lecture and two parts group exercise/workshop. Activities will include:

  • Reviewing change control requirements and common pitfalls
  • Dissecting an example change control procedure and discuss how it complies/does not comply with requirements and how ‘user friendly’ the procedure is to enable the change control program to work efficiently
  • Distributing case studies to the class for group review and discussion to apply course learnings

Who Should Attend

This training course is designed for the following pharmaceutical personnel:

  • Manufacturing
  • Quality
  • Regulatory Affairs
  • Laboratory Science
  • Information Technology
  • Validation
  • Engineering

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

  • Describe the regulatory requirements for change management and explain the need for a comprehensive change control program
  • Recognize the disciplines within your company which must be involved in change control
  • Apply all necessary elements to improve or construct a compliant, user-friendly change control program

Standard

Member

On or Before January 29, 2019
$899

After January 29, 2019
$999

Nonmember

On or Before January 29, 2019
$1,079

After January 29, 2019
$1,199


Government/Health Authority/Academic*

$599

*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 Accommodations and 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 February 13, 2019, no fee will be charged. After February 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 February 13, 2019, a full refund will be given minus a $200 fee. After February 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.

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:

Marriott Marquis San Diego
333 West Harbor Drive
San Diego, CA USA 92101

Contact

For more information, please contact:

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

Peter D. Smith, Principal, Smith GMP Consulting

Peter Smith formed his own company following retirement from PAREXEL Consulting in April 2018 where he worked for 23+ years in various positions. His last position was Vice President, Technical where he worked with clients in the pharmaceutical and biologics industry worldwide, which continues with his current company. Mr. Smith joined PAREXEL (then KMI) in 1994 following a 22-year FDA career. At the FDA, he worked in the field and at headquarters as an Investigator, specializing in pharmaceutical GMP/GCP and medical device inspections. His last position at FDA was Associate Director, International and Technical Operations Branch, Division of Field Investigations. In this capacity, he managed the FDA’s Foreign Inspection Program. During his FDA career, he conducted inspections of pharmaceutical plants in the U.S., Europe, Asia, South America and Australia. Mr. Smith has primary expertise in GMPs for sterile and non-sterile drug dosage forms, active pharmaceutical ingredients, management of inspections, including Pre-approval and foreign inspections, GMP quality systems and FDA regulatory issues. He has experience in antibiotics, radiopharmaceuticals, non-clinical (GLP) laboratory studies, and GCP compliance. He works with biologics and pharmaceutical client companies to achieve site facility compliance, implement GMP/Quality System corrective action plans, prepare clients for successful regulatory inspection outcomes, due diligence audits, and conducts GMP audits and assessments. He is a highly experienced public speaker and trainer in GMP and FDA inspection readiness topics. Mr. Smith holds a BS in Biology from Roger Williams University, Bristol, Rhode Island. He is a member of PDA, ISPE and RAPS, and is an Associate Adjunct Professor at the University of Rhode Island, College of Pharmacy, providing lectures to pharmacy students.

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 #573 | ACPE #0116-0000-18-026-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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https://store.pda.org/Meetings/Login.aspx?ID=4775

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