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PDA Metro Chapter: "How to Audit Sanitary Design of Non-Sterile Product Manufacturing"

Sep 10 - Sep 10, 2019
Bridgewater, NJ

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Overview

Join your PDA Metro Chapter for an evening discussion on microbiological contamination prevention in the non-sterile manufacture of drugs and consumer products being paramount in a robust and reliable supply chain, and consumer safety environment.

During this discussion and presentation we will focus on what a microbiological risk assessment is, where to focus in the manufacturing facility and, share lessons learned from inadequate outcomes from assessments.

The primary areas of focus include:

  • Equipment design
  • Equipment preventative maintenance
  • Cleaning of equipment
  • Sanitization of equipment
  • Water system design and microbiological controls
  • Raw materials
  • Personnel

As you know, Microbiology is a highly variable life-science. Relying solely on QC testing of materials and final products is not a leading indicator of contamination control, as sampling of these is minuscule compared to the overall size of the batch.

Placing emphasis on the above discussion points will drive assurance that each system is under control, by design, not by testing.

Furthermore, we are all consumers and patients, and nobody wants to use consumer products and/or drugs which are contaminated with potential pathogenic microorganisms, and no company who manufactures them wants to face recalls, and the damaging publicity associated with them.

Therefore, we as quality assurance/control microbiologists, have an obligation to ensure that the drugs and products our company manufactures are safe to use, and will remain stable during shelf-life, as our population of consumers/patients is vast, from infants, to children, adolescents to adults to elderly.

Please submit questions to our speaker at [email protected]

More information coming soon.

Agenda

    • 5:00 pm - 6:00 pm Registration Begins (Cash Bar, Food and Vendor Booths will open)
    • 6:00 pm - 7:00 pm Dinner
    • 7:00 pm - 8:30 pm Welcome, Seminar, Panel Q&A and Closing Remarks

Highlighted Speakers

Andrew  Dick
Andrew Dick
Johnson & Johnson

Travel

Sanofi

55 Corporate Drive
Bridgewater, NJ

Directions

Registration Fees

Early Registration Price
Registration Type Price By Aug 26th
PDA Member $59.00
PDA Non-Member $74.00

CANCELLATION POLICY: Substitutions or cancellations are permitted before Aug 26th.

GROUP DISCOUNT: Special discounts are available for registrants from the same company. A multiple pre-registration discount is applicable for $10 off each additional attendee of 3 or more.

Please contact Katie Ruiz ([email protected]) for multiple attendees discount.

Regular Registration Price
Registration Type Starting Aug 27th
Late & Walk-Ins (All) $99.00

CANCELLATION POLICY: On August 27th or after, no cancellations are allowed, but substitutions are welcomed.

GROUP DISCOUNT: Special discounts are available for registrants from the same company. A multiple pre-registration discount is applicable for $10 off each additional attendee of 3 or more.

Please contact Katie Ruiz ([email protected]) for multiple attendees discount.

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