Comparing GLP with GMP

  • Speaker:Ludwig Huber
  • Date: 19th February 2018 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90228

$279

refer

Refer Friend's


Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be mailed to you.
  • Login to the session using the username and password provided to you.
  • Get answer to your queries through interactive Q&A sessions via chat.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve.
  • Get certification of attendance.

Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

(More 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 it for 6 months from any location

$279

CD: Shipped within 2 working days

$409

5 Member Group: Access the Live Meeting online from any location globally

$2,569

10 Member group: Access the Live Meeting online from any location globally

$4,229
For discounts and offers call support

Related Products

Validation and Control of Excel Spreadsheets in Regulated Environments

Validation and Control of Excel Spreadsheets in Regulated Environments

We offer face to face in person seminar for companies/ corporate. Contact our support to set up a date and price. Description:Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel®..

$279

FDA's New Enforcement of 21 CFR Part 11

FDA's New Enforcement of 21 CFR Part 11

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. Why should you attend:FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic reco..

$189

Medicare's New Market-Based Pricing System for Clinical Diagnostic Laboratory Services

Medicare's New Market-Based Pricing System for Clinical Diagnostic Laboratory Services

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.This online training will cover Medicare’s new market-based payment system mandated by PAMA for clinical diagnostic laboratory tests including final 2018-2020 payment rates released by CMS, regulatory requirements, guidance and related government reports on implementing a new Part B fee schedule for l..

$269