FDA Inspections: Developing Effective Readiness Strategies

 Course Director: Jackelyn Rodriguez

 Course Cost |  Course Location |   Course Date

Best Practices for an Effective Quality Assurance Auditing for FDA Regulated Industries & ISO13485 -MEDSAP

 Course Director: Jackelyn Rodriguez

 Course Cost |  Course Location |  Course Date

How to Implement Risk Management Principles and Activities Within a Quality Management System

 Course Director: Jackelyn Rodriguez

 Course Cost |  Course Location |   Course Date

An Effective Risk Based Approach to Auditing and Qualifying Suppliers and Vendors

Course Description
Course runs 9:00 to 5:00 both days (Breakfast  & Lunch Included)
The auditing and qualifying training course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product.

Computer System Validation – A based risk approach

Course Description
Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
This computer system validation course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations.

Reporting Failure Investigations and Process Deviations

Who Should Attend
Because of its comprehensive content, this course will prove most valuable to personnel in research and development, manufacturing, quality assurance, and quality control laboratory, who are involved in conducting and reporting failure investigations and deviations.

Overview of FDA cGMP Compliance for Drugs and Biotech Products

Course Description
This course was developed for those employees in the pharmaceutical industry who need to have the basic understanding of Current Good Manufacturing Practices.

Good Manufacturing Practices Training | A practical approach to understanding GMPS

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 (Breakfast and Lunch Included)
This Good Manufacturing Practices training covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. Current Good Manufacturing Practices (cGMPs) are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the GMP course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution.