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PDA 352 Sterile Pharmaceutical Dosage Forms: Basic Principles

Apr 07 - Apr 08, 2022
Dallas, TX

  • Education
  • The Americas
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Program Highlights

SPECIAL DISCOUNT: Attend this training course for only $899 when you register by 11 March and use campaign code AM22TRAINING.

Overview

Gain knowledge of the basic principles of sterile pharmaceutical dosage forms required to improve processes by utilizing effective approaches to process validation and sterility assurance, and prepare for regulatory inspections based on current inspection trends for parenteral manufacturing. This introductory two-day training course will address cleanroom design, environmental monitoring and control, sterilization principles, manufacturing unit operations, aseptic filling, dosage form development, packaging and stability requirements, validation of aseptic processing (media fills), product specific validation, QA/QC for parenterals, and regulatory trends. Half of the training course content will cover small molecules and the other half will cover biologics.

For more options and/or related training courses, please visit the page(s) below.

PDA Biopharmaceuticals Training Courses
PDA Annual Meeting Training Courses

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Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

John Ludwig
John Ludwig
Pfizer, Inc.
Bio
John Ludwig
Pfizer, Inc.

John leads the Medicinal Sciences organization in Pfizer R&D which includes five-line disciplines: BioMedicine Design, BioTherapeutics Pharmaceutical Sciences, Medicine Design, Pharmaceutical Sciences Small Molecule, and Global Clinical Supply.

John began his career at Burroughs Wellcome Co. in 1989 as a pharmaceutical formulator and worked on a variety of dosage forms including liquid and lyophilized parenterals, topical creams and ointments, and oral liquids. He joined Searle, Inc. in Skokie, IL in 1995 responsible for parenteral product formulation and process development, clinical manufacturing, technology transfer/validation, and the R&D microbiology function. In 2001, he transferred to Chesterfield, MO, as Site Leader for the Bioprocess and Formulation Technology organization (Pharmacia, Inc.). Following the Pfizer acquisition in 2003, John led the combined Pharmaceutical and Analytical R&D line for Pfizer Global Biologics and from 2007-2009 the Analytical R&D organization. Following the Wyeth acquisition, John led the Business Strategy, Operations, and Clinical Supply Planning function, and served as Site Director for Pfizer St. Louis Laboratories. In 2012, he became leader of BioTherapeutics Pharmaceutical Sciences. John assumed his current position in 2017.

John is active in the American Association of Pharmaceutical Scientists and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to the development of three professional training courses and serves regularly as a course instructor for PDA.

John received a B.S. in Pharmacy and Ph.D. in Pharmaceutics from the University of Tennessee, Memphis.

Sandeep Nema
Sandeep Nema
Pfizer, Inc.
Bio
Sandeep Nema
Pfizer, Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the basic principles of cleanroom facility design, environmental monitoring, and aseptic processing
    2. Summarize the design and interpretation of media fills
    3. Describe product specific validation for parenteral dosage forms
    4. Discuss aspects of dosage form development, packaging, and stability
    5. Describe the chemical composition of endotoxins, their toxic effects, sources, and testing procedures
    6. Summarize the CGMP regulatory and inspection trends for parenteral manufacturing
  • Who Should Attend

    This training course is intended for professionals who are involved in sterile formulation/process development and sterile drug manufacturing.

    Departments
    Manufacturing, Packaging, Quality Assurance

    Roles
    Specialist, Supervisor, Manager, Scientist, Engineer

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Travel

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.

Hyatt Regency Dallas

300 Reunion Boulevard
Dallas, TX

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  • Accommodations

    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 Hyatt Regency Dallas. The rate is $249 for single or double occupancy. Guestroom rates are subject to discounted resort fee ($20 per night) and State and Local taxes.

    Reservations must be secured by Friday March 4, 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 11:00 a.m.

    To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Be sure to tell the reservationist that you are with the PDA 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 in advance of arrival date, unless otherwise specified on your reservation information.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Alaska Airlines, Delta and Southwest service this airport. Taxi fares from DFW are approximately $45-50 one way, not including tip. Taxi fares from DAL are approximately $20-25 one way, not including tip. App based rides are available to/from the airport.

By Car

The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Valet Parking, operated by PMSI, is available at hotel entrance. In and out privileges for hotel guests only. Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. In and out privileges for overnight guests only, operated by PMSI. Self Parking Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower $19 Radish Lot, 0–4 hours | $9 Radish Lot, 4–8 hours | $13 Radish Lot, 8-24 hours | $19 B-Lot, 0–4 | $7 B-Lot, 4–8 hours | $13 B-Lot, 8-24 hours | $19 Valet Parking Overnight Guests |$32 + tax 0–4 hours | $22 4–8 hours| $26 8–24 hours | $32

Other Options

Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Please call 214 653 1101 for train information. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Please call 214 849 6831 for bus information. DART Light Rail Service: the hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries.

Directions

Registration Fees

Early Registration
Registration Type Price By February 21, 2022
Member $1,349
Non-member $1,619
Gov't/Health Auth./Academic* $1,049

Regular Registration
Registration Type Price After February 21, 2022
Member $1,499
Non-member $1,799
Gov't/Health Auth./Academic* $1,049

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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