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Roger Cowan

Roger Cowan is the Keynote Spaker at Compliance Key Inc. He is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada. 

Roger's areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control. 
website: www.pharmaconsultation.com   

 Webinar Id: LSHCRC010
10:00 AM PT | 01:00 PM ET
 08/16/2018
 Duration 60 mins

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.  Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safet........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $368
Multiple Attendee
( 2 - 5 Participants)
          $741
Corporate Attendee
( 6 - 10 Participants)
                   $167
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCRC012
10:00 AM PT | 01:00 PM ET
 10/16/2018
 Duration 60 mins

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system is essential for assuring the quality and safety of the pharmaceutical product. Proper understanding and testing of the sterile filtration system according........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $368
Multiple Attendee
( 2 - 5 Participants)
          $741
Corporate Attendee
( 6 - 10 Participants)
                   $167
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCRC013
10:00 AM PT | 01:00 PM ET
 11/06/2018
 Duration 60 mins

CMO Supplier Quality Agreements :- How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturer

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts: EU GMP Chapter 7 "Outsourced Activities" (Revised) Draft Guidance for Industry -"Contract Manufacturing A........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $368
Multiple Attendee
( 2 - 5 Participants)
          $741
Corporate Attendee
( 6 - 10 Participants)
                   $167
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCRC014
10:00 AM PT | 01:00 PM ET
 12/04/2018
 Duration 60 mins

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a giv........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $368
Multiple Attendee
( 2 - 5 Participants)
          $741
Corporate Attendee
( 6 - 10 Participants)
                   $167
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCRC011
 6 months unlimited
 Duration 60 mins

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.  Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRC007
 6 months unlimited
 Duration 60 mins

CMO Supplier Quality Agreements :- How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturer

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts: EU GMP Chapter 7 "Outsourced Activities" (Revised) Draft Guidance for Industry -"Contract Manufacturing A........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRC005
 6 months unlimited
 Duration 60 mins

Pharmaceutical Compressed Air :- Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCGRG002
 6 months unlimited
 Duration 60 mins

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a giv........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCSRC001
 6 months unlimited
 Duration 60 mins

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system is essential for assuring the quality and safety of the pharmaceutical product.  Proper understanding and testing of the sterile filtration system accordin........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHRC003
 6 months unlimited
 Duration 60 mins

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.  Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safet........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCRC004
 6 months unlimited
 Duration 60 mins

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system is essential for assuring the quality and safety of the pharmaceutical product. Proper understanding and testing of the sterile filtration system according........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHRC002
 6 months unlimited
 Duration 60 mins

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.  Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHRC001
 6 months unlimited
 Duration 60 mins

CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts: EU GMP Chapter 7 "Outsourced Activities" (Revised) Draft Guidance for Industry -"Contract Manufacturing Ar........

$167 Recorded (6 months unlimited access)


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