PDA 352 Sterile Pharmaceutical Dosage Forms: Basic Principles

Bethesda, MD
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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:

  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. Describe fundamentals of dosage form development, packaging, and stability, and unique aspects for mRNA, CGT and other biologics
  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

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

Early Bird Pricing

Register before 26 August 2024

Early Bird Member Price

$1,349

GovernmentMember 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

$1,499

GovernmentMember Only

$1,049

Health AuthorityMember Only

$1,049

AcademicMember Only

$1,049

Non-Member

$1,799

See Qualifying Criteria for Member Types.

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

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.

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

How to Get Here
By Air The following airports are near the training course location: 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 $13/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.
By 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.