Training Doyens

OVERVIEW Effective and compliant computer system validation is criticalto any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience. FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. In this FDA Compliance Training, you’ll learn all about how to prepare your system validation documentation for an FDA audit of your company’s computer systems. FDA Auditor Training By Carolyn Troiano WHY SHOULD YOU ATTEND It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need ...

OVERVIEW In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required documentation, formats, archiving, as well as how to respond to inspection and audit results. WHY SHOULD YOU ATTEND One should attend this webinar to increase one’s knowledge ofFDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. One will gain a better understanding of the parameters, approaches, and concerns of FDA inspectors. One will also gain a more in depth understanding of how to prepare for unannounced FDA audits and inspections. GMP Training AREAS COVERED The insp...

OVERVIEW This webinar will concentrate on the key attributes of aneffective cGMP investigation, the role of management, quality control tools, CAPA effectiveness and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Inadequate investigations” “Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated. A written record of the investigation shall be made and shall include the conclusions and follow-up.” 21CFR Part 211.192. Implementing an effective system of conducting investigations that, ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is a critical requirement for the manufacture and sale of all FDA regulated products. GMP Investigations WHY SHOULD YOU ATTEND Any FDA inspection will ask to review yo...