cGMPs in the Quality Control Laboratory (Medical 2018)
ENDED
Training by
Compliance4All
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On-Site
/ Training
USD 150.00
Details
Overview:
In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and provide a stimulus to initiate preventive actions.
Why should you Attend:
In this webinar the discussion will begin by identifying non-conformances most often cited by the FDA and the pertinent regulation. This will be followed by a discussion of specific observations that relate to the laboratory cited in Warning Letters and FDA 483s.
Areas Covered in the Session:
System Based Inspection Guidance
Laboratory Control System
Most common observations in the laboratory
483 and Warning letter observations
Analysis of observations
Areas for preventive action
Who Will Benefit:
Quality Control Laboratory Managers
Quality Control Laboratory Supervisors
Quality Control Analysts
Quality Control Microbiologists
Quality Assurance Manages
Quality Auditors
Speaker Profile:
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
In this webinar we will apply one aspect of this proactive approach, the review regulatory requirements and analysis of 483 and Warning Letter observations to determine if similar observations could be made in the participants facility and provide a stimulus to initiate preventive actions.
Why should you Attend:
In this webinar the discussion will begin by identifying non-conformances most often cited by the FDA and the pertinent regulation. This will be followed by a discussion of specific observations that relate to the laboratory cited in Warning Letters and FDA 483s.
Areas Covered in the Session:
System Based Inspection Guidance
Laboratory Control System
Most common observations in the laboratory
483 and Warning letter observations
Analysis of observations
Areas for preventive action
Who Will Benefit:
Quality Control Laboratory Managers
Quality Control Laboratory Supervisors
Quality Control Analysts
Quality Control Microbiologists
Quality Assurance Manages
Quality Auditors
Speaker Profile:
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Outline
Special Offer
One Dial-in One Attendee
Price: $150.00
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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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