Auditing Laboratories Conducting Assays Supporting Biologics

Overview:
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.

Why should you Attend:
Auditing vendors is an essential function for quality and scientific personnel. 

Training and clarification of the process necessary for good audits is important for Sponsors gathering the necessary information to qualify a vendor laboratory or to document that procedures are following standard expectations of GMP and GLP.

Areas Covered in the Session:
Assessments during the walk-through
Setting the timing
Identifying potential quality issues
Presenting findings
Negotiating responses

Who Will Benefit:
Pharmacists
Consultants
Pharmaceuticals
Biopharmaceuticals
Botanicals
Natural Products

Speaker Profile:
Gwen Wise-Blackman, Ph.D. has over 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals where she successfully managed multiple projects and held positions of increasing accountability for scientific and quality expertise.

Event Fee: One Dial-in One Attendee Price: $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]