Carl Patterson
QA Specialist
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, related to aseptic processing, have been met.
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Recorded Webinar
Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing
The webinar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.
Recorded Session Get life time access for one participant with download option!

USP 1224 Transferring the Method to meet Regulatory Expectations
The critical points of USP <1224> and the regulatory requirements required by the USP and FDA. USP <1224> is very specific on what is required for tech transfer of analytical methods as well as the responsibilities of the participating parties.
Recorded Session Get life time access for one participant with download option!

Effective Pharmaceutical GMP Audits and Self-Inspections
Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality and also in the management of outsourced activities and purchased materials.
Recorded Session Get life time access for one participant with download option!

Monitoring and Validation of Pharmaceutical Water Systems
This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled for impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced meets specifications around the clock. Learn common pitfalls with water system design and use and how to avoid them. Get your pharma water questions answered in this webinar.
Recorded Session Get life time access for one participant with download option!

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
CGMP drug products rely on the bacterial Endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
Recorded Session Get life time access for one participant with download option!

GMP Audits: Tools and Techniques
This webinar will provide the tools and techniques used during a GMP Audit. It will cover the basic requirements for a GMP Audit and will provide the information needed to successfully conduct an audit.
Recorded Session Get life time access for one participant with download option!

Microbiological and Business Risk of Not Testing Raw Materials for Microbial Presence
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
Recorded Session Get life time access for one participant with download option!

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
cGMP drug products rely on the bacterial Endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
Recorded Session Get life time access for one participant with download option!

Objectionable Microorganisms - Knowing What and Where You Can Find Them in Biopharmaceutical Manufacturing
Objectionable microorganisms are considered, if discovered, harmful to the patient. By identifying and controlling these microorganisms and putting the appropriate controls in place early in the pharmaceutical manufacturing or medical device manufacturing processes problems in the patient can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place. By knowing, where, when, why, and how objectionable microorganisms exist, harmful consequences to the patient can be prevented.
Recorded Session Get life time access for one participant with download option!

Effective Pharmaceutical GMP Audits and Self-Inspections
Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality and also in the management of outsourced activities and purchased materials.
Recorded Session Get life time access for one participant with download option!

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable so as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
Recorded Session Get life time access for one participant with download option!

Creating an Effective Contamination Control & Environmental Monitoring Program
This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This webinar will provide different avenues of approach to determine the source of contamination and how to deal with the contamination once the source is discovered.
Recorded Session Get life time access for one participant with download option!

Microbiological and Business Risk of not Testing Raw Materials for Microbial Presence
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
Recorded Session Get life time access for one participant with download option!

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production
This webinar will review the regulations pertaining to objectionable microorganisms, testing and identifying objectionable microorganisms, and putting appropriate controls into place to prevent harming patients.
Recorded Session Get life time access for one participant with download option!

Creating an Effective Contamination Control & Environmental Monitoring Program
This webinar will provide an overview of environmental monitoring and provide aspects of contamination control. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This webinar will provide different avenues of approach to determine the source of contamination and how to deal with the contamination once the source is discovered.
Recorded Session Get life time access for one participant with download option!

Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing
The webinar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.
Recorded Session Get life time access for one participant with download option!

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