Objectionable Microorganisms- Pathogen Specific Assessments

The topic of objectionable organism is often discussed but defining what is objectionable is a challenge. From validating the microbial identification to assessing the true risk to the patient, there are many steps that require clinical microbiology knowledge and thorough research.

This webinar will provide guidance on the various steps involved before concluding that the contaminant is objectionable or not objectionable in the product.

Which industries does this webinar apply to? 

Pharmaceuticals, Biotechnology, Medical Device, Cell and Gene Therapies and Pharmacies

Who will benefit? 

Quality Assurance, Quality Control, Microbiology, Regulatory Affairs, Facilities, Manufacturing and Training. 

Time of event 

10:30am to 12:30pm PST 

1:30pm to 3:30pm EST 

Webinar instructions

Webinar login information will be sent to registered attendees 48 hours prior to webinar start

Base Cost/Person: $225

    Discounts:
  • 2+ people = $180 (Per Attendee)

Myths, Mistakes and Misunderstandings Related to Airflow Visualization(Smoke Studies)

Airflow visualization is a science not unique to the pharmaceutical industry. Airflow visualization and air pattern analysis have been utilized by many industries in order to characterize airflow patterns. As air is invisible, the behavior of tracer particles added to the airstream are observed, recorded and analyzed.

It is important that the tracer particles faithfully follow the air patterns and the documentation methods are suitable.

The multitude of FDA 483 observations and warning letters citing data integrity for; environmental monitoring, media fill and product sterility testing data begins with poorly executed airflow visualization studies (smoke studies).

The increased scrutiny by regulatory agencies regarding smoke studies is indicative of regulator’s lack of confidence in outdated approaches to contamination control as well as concerns over aging facilities and obsolesced systems.

The “c” in cGMP stands for current and per the FDA; “systems and equipment that may have been top of the line to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.”

This training will address the common errors and misunderstanding related to smoke studies, specifically addressing updated regulator thinking.

Which industries does this webinar apply to? 

Pharmaceuticals, Biotechnology, Medical Device, Cell and Gene Therapies and Pharmacies

Who will benefit? 

Quality Assurance, Quality Control, Microbiology, Facilities, Engineering, Manufacturing, Validation and Training. 

Time of event 

10:30am to 12:30pm PST 

1:30pm to 3:30pm EST 

Webinar instructions

Webinar login information will be sent to registered attendees 48 hours prior to webinar start

Base Cost/Person: $225

    Discounts:
  • 2+ people = $180 (Per Attendee)