Comparing GLP with GMP

  • Speaker:Ludwig Huber
  • Duration:60Min
  • Product Code:GRC-90228

$279

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Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. 

Description:

Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also significant differences. There are many  questions about the differences and similarities between both of them and when and how exactly to apply one or the other and how Good Clinical Practice regulations (GCPs) fit between GLP and GMP. This seminar will have all the answers.


Topics to be Covered:
•    Regulations along the drug lifecycle: GLP, GCP, GMP
•    Frequent misconceptions
•    Clarify objectives, the scope and applications of GLP vs. GMP
•    Common requirements of GLP and GMP
•    Key organizational differences and execution of tasks
•    Key documents required by the FDA
•    Going into  details of similarities/differences: procedures, personnel, equipment, methods, stability testing, reserve samples, raw data, archiving of records
•    Effectively moving from GLP to GMP: step-by-Step
•    Expanding GMP to GLP: Step-by-Step
•    GLP and GMP in a single environment: what to care about
•    Circumstances  when research labs must comply with GMP or GLP
•    FDA inspections: timing, focus, enforcement in GLP vs. GMP

Who will benefit:

•    QC managers
•    QA managers and personnel
•    Laboratory managers and supervisors
•    Analysts
•    Regulatory affairs
•    Training departments
•    Documentation department
•    Consultants

Target Companies:
•    Small, midsize and large Pharmaceutical companies
•    API manufacturers
•    Contract laboratories
•    Clinical testing laboratories
•    GLP facilities
•    CROs
•    Medical device industry

Instructor Profile:
Ludwig Huber, Ph.D., is the director and editor of Lab Compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.

Available Options

Recording: Access the training Recording for 6 months from any location

$279

CD: Shipped within 2 working days

$409

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$2,569

10 Member group: 10 can Attend Live Meeting Online from any location globally

$4,229

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