ComplianceOnline

Register

Toll Free: +1-888-717-2436


customer care
Fax: +1-650-963-2556
Email: editor@complianceonline.com
Read Frequently Asked Questions

Quality Practices for Research and Development (R&D) CMC Laboratories

Buy Now Section

This Quality Practices for R&D CMC Laboratories training will associate with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.

Speaker
Instructor: Nadine M Ritter
Product ID: 701513

Why Should You Attend:

During product development, many experimental CMC studies to support process development and product characterization are conducted in non-GMP laboratories, including academic and contract facilities. However, the data generated in these studies may be utilized in product regulatory filings, making them subject to concerns about traceability and reproducibility. While there are no formal compliance requirements for R&D laboratories, emerging regulatory concepts in quality systems and quality by design place greater compliance pressure on R&D labs for sound scientific practices. Additionally, early-phase quality control testing may be performed in laboratories that are not fully GMP compliant, and are in fact much closer to R&D than GMP.

Areas Covered in the Seminar:

Who Will Benefit:

This webinar is for anyone associated with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.

Instructor Profile:

Nadine M. Ritter,Ph.D., senior consultant for Biologics Consulting Group, Inc., is a protein chemist with expertise in the chemistry, manufacturing and control (CMC) of biotechnology products. She is past Director of Analytical Services Division at major contract testing organization performing R&D, GLP and GMP analytics studies. For over 15 yrs, she has contributed data to numerous US and international regulatory IND/IMP and BLA/NDA/MAA filings. Nadine also has considerable experience conducting audits of sponsor and contract laboratories worldwide. She is a member of several professional analytical organizations, and is frequently invited as a speaker and writer on analytical and stability issues.

Bookmark and Share
Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

Auditing and Administrating Human Resource Policies and Practices - 80024SEM
FDA's GMP Expectations for Phase - 80039SEM

This training hasn't been reviewed yet.

Review this training

Training Options