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Change Management – A Practical Workshop - Option 1

Mar 15, 2019
San Diego, CA

  • Education
  • The Americas


This training course will help you understand 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.

During this training course, you will learn about change control review requirements and common pitfalls, change control procedures and how it complies/does not comply with requirements and how ‘user friendly’ the procedure is to enable the change control program to work efficiently. Relevant case studies will be used to discuss and apply change management principles.


Peter D. Smith
Peter D. Smith
Smith GMP Consulting

Additional Information

  • Learning Objectives

    Learning Objectives

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

    Who Should Attend

    This training course is intended for professionals who are involved in sterile drug manufacturing change control procedures.

    Manufacturing, Quality Assurance, Quality Control, Validation

    Specialists, Supervisors, Managers

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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Marriott Marquis San Diego

333 West Harbor Drive
San Diego, CA

  • Accommodations

    Marriott Marquis San Diego
    333 West Harbor Drive
    San Diego, CA USA 92101
    Tel: +1 (619)-234-1500

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Marriott Marquis San Diego. The rate is $289* for single or double occupancy. *Guestroom rates are subject to State and Local taxes, 10.5% occupancy tax, 2% San Diego Tourism Marketing District tax and $0.77 Commerce Fee per room per night. Tax rates are subject to change without notice. Reservations must be secured by Monday, February 11, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Marriott Marquis San Diego at +1 (888) 236-2427. Please make sure to tell the reservationist that you are with the PDA group attending the 2019 PDA Annual Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival to avoid cancellation fees.

  • Amenities

    Read about the amenities offered at the Marriott Marquis San Diego.

How to Get Here

By Air

San Diego International Airport (SAN) is located 3.3 miles (about 15 minutes) northeast from the Hotel. Taxis are on standby at the San Diego International Airport (SAN), offering service to and from the Marriott Marquis San Diego for an approximate fare of $18 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 15 minutes.

By Car

Directions from San Diego International Airport
Turn left on Harbor Drive. Follow Harbor Drive along waterfront. Hotel will be on right (about 2 miles).

Parking at the Hotel
Self-parking at the Marriott Marquis San Diego is $10 hourly, $35 daily. Valet parking is $50 daily.

Other Options

More information coming soon.


Registration Fees

Early Registration
Registration Type Price By January 29, 2019
Member $899 $599
Non-member $1,079 $599
Gov't/Health Auth./Academic* $599

Regular Registration
Registration Type Price After January 29, 2019
Member $999 $599
Non-member $1,199 $599
Gov't/Health Auth./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 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 [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Feb 13, 2019, no fee will be charged. After Feb 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 Feb 13, 2019, a full refund will be given minus a $200 fee. After Feb 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


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