PDA 352 Sterile Pharmaceutical Dosage Forms: Basic Principles
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Individual Registration
Group Registration
Gain knowledge of the basic principles of sterile pharmaceutical dosage forms required to effectively approach formulation design, process development, scale-up, validation, sterility assurance, and regulatory inspection preparation 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, primary packaging and stability requirements, validation of aseptic processing (media fills), product specific validation, QA/QC for parenterals, and regulatory trends. The training course will include relevant information as it applies to small molecules, biologics, antibody-drug conjugates (ADCs), vaccines, and cell/gene therapy (CGT) modalities.
Upon completion of this training course, the attendee will be able to:
- Describe the basic principles of cleanroom facility design, environmental monitoring, and aseptic processing
- Summarize the design and interpretation of media fills
- Describe product specific validation for parenteral dosage forms
- Describe fundamentals of dosage form development, packaging, and stability, and unique aspects for mRNA, CGT and other biologics
- Describe the chemical composition of endotoxins, their toxic effects, sources, and testing procedures
- Summarize the CGMP regulatory and inspection trends for parenteral manufacturing
For more options and/or related training courses, please visit the following page(s):
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Early Bird Pricing
Register before 26 August 2024
Early Bird Member Price
$1,349GovernmentMember Only
$1,049
Health AuthorityMember Only
$1,049
AcademicMember Only
$1,049
Non-Member
$1,619
Standard Pricing
Register after 26 August 2024
Standard Member Price
$1,499GovernmentMember Only
$1,049
Health AuthorityMember Only
$1,049
AcademicMember Only
$1,049
Non-Member
$1,799
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].
Featured Trainers
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John Ludwig, PhD
Pfizer, Inc.
Read Bio
John Ludwig, PhD
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.
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Sandeep Nema
Pfizer, Inc.
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Request InformationPLEASE 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.
PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD 20814, USA
ACCOMMODATIONS
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD
20814