cGMPs in the Quality Control Laboratory (Medical 2018)

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]

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WHEN AND WHERE

14 September 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Health