webinars

Why Validated Systems Fail-A part of Microrite’s complimentary webinar series

Often companies face system failures or product quality issues despite being validated. Without well defined process understanding and product requirements, flawed facilities, equipment or process design can occur. Successful validation depends upon multiple milestones; each addressed with a thorough knowledge base and process control.

This complimentary webinar will outline the gaps in validation that have lead to severe consequences, delays in production and even regulatory scrutiny.

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, Engineering, Facilities, Validation, Manufacturing and Training

Time of event

11:00am to 12:00pm EST

8:00am to 9:00am PST

Webinar instructions

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

webinars

Micro Contamination and Static Charge-A part of Microrite’s complimentary webinar series

The detrimental effects of static electricity in cleanroom manufacturing are well known in the electronics, flat panel display and disk drive industries but are completely unrecognized in healthcare manufacturing industries. This results in significantly reduced profitability for the healthcare industries.

Static charge is thought of as electrostatic discharge or little blue sparks. This indeed occurs and will destroy a computer chip but it is not the reason to control static charge in the pharmaceutical or medical device manufacturing cleanroom. A variety of issues including micro contamination control are the issue that is critical to a healthcare factory and will be explained in this short session.

Static charge grows to much higher levels in the cleanroom than in the conventional room. Learn why and where the charge is most likely to appear. This will be the key to establishing a program to limit charge and minimize its effects on factory yield and smooth operations.

In this briefing, you will learn the major effects of static charge on healthcare manufacturing facilities. Emphasis will be placed on details of microcontamination escalation in a charged environment but the effects on robotics and on precision weighing will also be addressed.

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, Engineering, Facilities, Validation, Manufacturing and Training

Time of event

11:30am to 12:00pm EST

8:30am to 9:00am PST

Webinar instructions

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

webinars

The Science Behind Smoke Studies-A part of Microrite’s complementary webinar series

The increasing number of FDA 483 observations related to smoke studies eludes to a gap in understanding the science, methodology and the purpose behind this important contamination control tool. Airflow visualization is a science not unique to the pharmaceutical industry. The purpose of smoke studies is to characterize and map airflows to detect any deviant or questionable airflow patterns.

These myriad smoke study related observations are indictors of the regulator’s suspicion of contaminated product or data integrity. The recent scrutiny regarding airflow visualization reflects a more astute regulatory body that understands the effect of cleanroom design and airflow on product quality.

Airflow visualization has evolved from a simple test with some videos to becoming a critical component of a holistic contamination control strategy. Airflow visualization, if executed and documented correctly, provides a tool to optimize the contamination control effect of clean air in conjunction with material and operator movements.

This session will dissect recent regulator’s comments and observations and explain why the technology and methodology are crucial for detecting inappropriate airflows.

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, Engineering, Facilities, Validation, Manufacturing and Training

Time of event

11:00am to 12:00pm EST

8:00am to 9:00am PST

Webinar instructions

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

webinars

Mold Contamination Do’s and Don’ts

Often the risk of mold contamination is not addressed until contamination has happened!

Understanding where mold gets into your facility; how mold can grow in the facility and in process materials can assist a company to comprehend possible mold contamination of the product.

Managing mold contamination thoroughly is an imperative process for any healthcare and life science related industry. All mold cannot be put in the same basket as they do not behave or propagate the same way, nor react to disinfectants in the same manner.

Often mold contamination leads to major facility and process design changes after it has made its presence known in the cleanroom in large quantities or has ended up in the product.

This course will save unnecessary facility remediation by identifying the root cause of contamination thru helping you understand if you are creating Biotic and Abiotic factors for mold to grow!

Which industries does this webinar apply to?

Pharmaceuticals, Biotechnology, Medical Device, Cosmetics, and In Vitro Diagnostics

Additionally, companies that use refrigeration as a storage method, or those who use wood pallets or other cellulose based materials will greatly benefit from this webinar.

Who will benefit?

Quality Assurance, Quality Control Microbiologists, Facilities, Manufacturing Managers, Materials Management, and other life science professionals and related vendors.