PHARMACEUTICALS 2012 - Analytical Procedures and Procedures Transfer

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Category Pharmaceutical Analytical Procedures; Procedures Transfer; Quality Attributes; Drug Substance; Drug Product; Drug Development; Method Development; Validation of Procedures

Deadline: January 27, 2012 | Date: January 27, 2012

Venue/Country: Palo Alto, U.S.A

Updated: 2011-12-16 16:40:42 (GMT+9)

Call For Papers - CFP

This 6-hr virtual seminar on Analytical Procedures and Procedures Transfer will address procedure selection and assessment for pharmaceutical substances and products, ICH and USP guidelines for procedure validation and verification and how you can identify issues upfront to improve success of the project.

Why Should You Attend:

Analytical procedures are typically developed early in the clinical trial phases of drug development. During the movement of the product toward commercial product status, formulations change, concentrations change, and presentations change. It is crucial to assess and to re-assess the procedures that are being used throughout the lifecycle of the product.

Areas Covered in the Seminar:

- Review of typical procedures for pharmaceutical substances and products.

- Assessment of procedure appropriateness.

- ICH guidelines for validation.

- USP guidelines for validation and verification.

- Applications of the ICH guidelines for validation in transferring procedures.

- Debated topics and approaches.

- Complex procedures.

- Establishing boundaries.