Comparing GLP with GMP

  • Speaker:Ludwig Huber
  • Duration:60Min
  • Product Code:GRC-90354

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.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

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. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 
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: 6 Months Access to the Training which can be accessed from any location

$269

Recording Access to 8 Members: 6 months access to 8 participants. Recording can be accessed from any location

$749

CD-DVD: Shipped within 2 working days

$409

USB - Shipped within 2 working days

$429

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

$2,649

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$4,829

Related Products

Writing and Enforcing Effective SOPs

Writing and Enforcing Effective SOPs

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another stor..

$269

Validation and Control of Excel Spreadsheets in Regulated Environments

Validation and Control of Excel Spreadsheets in Regulated Environments

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 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 1..

$209

FDA Requirements for Computer System Validation

FDA Requirements for Computer System Validation

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description: The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software an..

$289

Requirements of Validation – IQ, OQ and PQ Protocols

Requirements of Validation – IQ, OQ and PQ Protocols

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:Validation is an important element of the Quality System Regulations and ISO13485.   This course will cover the requirements the essentials of validation.  You’ll learn about what processes needed to be validate..

$289

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..

$389

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. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description: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 an..

$269

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Certifications: GRCTS Attendance Certificate -Background:Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful proje..

$259

Implementing the Best Practices for FDA Inspection Preparation and Management

Implementing the Best Practices for FDA Inspection Preparation and Management

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. CertificationsGRCTS Attendance CertificateDescription: This seminar will discuss guidelines to adequately implement the best practices for FDA inspection preparation and management compliant with the Good Manufacturing Practices ..

$259