Analytical Method Validation under Good Laboratory Practices (GLPs)
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Good Laboratory Practices training (GLP) is essential to any laboratory that supports products for sale or use in the United States. GLP much like GMP ensures a comprehensive system that guarantees validity of results and overall quality. Pharmaceuticals, chemicals, petrochemicals, and environmental analyses companies mandated to be following GLP training. A central aspect of GLP is validation of an analytical method.
Completely new compounds are being developed each day in pharmaceuticals, structures that have never studied before by chemists. Their properties – such as solubility and acid-base nature, are unknown. Synthetic reactions may create similar types of molecules, including structural and optical isomers. The methodologies that warrant US FDA compliance with GLP regulations require being able to separate and identify all major, minor, and trace components. No longer is it just determining a purity of the main component, environmental analysis is a pre-requisite. As per GLP requirements, each minor contaminant or degradation product is also important.
Why You Should Attend:
This webinar will discuss analytical method validation and the best practices to follow, including components of a validation. We will also cover how to include critical reagents comparison, selectivity experiments, assessment of stability. The importance of communication between the development and the validation labs and accuracy of transfer documents (SOPs training) will also be addressed. Participants will be able to answer and understand – Is validation a regulated activity? Recognize when to pull the trigger for validation and the importance of suitability testing.
Areas Covered in the Session :
- Method Validation
- The criteria for a method
- Statistical requirements
- Documentation requirements
- Maintaining Compliance
- Common issues
Who Should Attend:
- Analysts
- Lab Supervisors and Managers
- QA Managers and Personnel
- Consultants
- Validation Specialists
- Chemists
Course Director: Dr. JOHN C. FETZER
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Refund Policy
Cancellation by Registrant:
- Registrants may cancel their registration for any reason up to 2 business days prior to the event. A refund will be issued minus a $45 administrative fee.
- If a cancellation occurs after materials such as documents, handouts, checklists, slide deck, or recordings have been sent by Eventura, only 40% of the registration fee will be refunded.
- If the registrant fails to cancel within the stipulated time or does not attend the event, no refund will be issued. Options available to the registrant in such cases include:
- Access to a one-time recording of the event.
- A redeemable voucher.
Substitutions of attendees may be made at any time by notifying Eventura via email.
Cancellation by Eventura:
- Eventura reserves the right to cancel or reschedule an event due to insufficient registrations or unforeseen circumstances. Registrants will be notified via email prior to the event's start time unless prevented by situation beyond control.
- If an event is rescheduled, registrants will be promptly informed of the new date and their registration will be automatically transferred.
- If the new date is not suitable, registrants may choose from the following options:
- Access to a one-time recording of the webinar after the live session.
- A redeemable voucher valid for 12 months, applicable towards any future live event or past recording.
- A full refund will be issued if no new date is provided within 90 days from the originally scheduled event date.
If an event is permanently cancelled, registrants may opt for:
- A recording of the webinar, if available.
- A redeemable voucher.
- A full refund.
Eventura reserves the right to modify some topics, materials, or speakers/instructors without prior notice.
Refund Processing:
Refunds are processed within 7 business days from the receipt of the refund request. Eventura World is not liable for any penalties or expenses incurred due to an event's cancellation.
For additional information or clarification regarding our refund or cancellation policies, please contact our support team by phone or email us at support@eventura.us. Include your transaction ID, event ID, and event date in the subject of your email.