Webinar On Risk Management in GMP Facilities

This FDA GMP training will help you understand the current requirements for raw material management with tips for practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

Areas Covered in the Session :

FDA requirements for raw material management at GMP facilities

Common risk management practices

Vendor selection and validation requirements

Product specific raw material issues: chemical, biologic and botanical raw materials

Suggested quality control measures

FDA’s common findings and possible resolutions

Trends in FDA inspection of raw material processes

Regional and multinational raw material providers

Raw material risk management in the global setting

Who Will Benefit:

Compliance/Regulatory affairs professionals

Managers of GMP facilities

Supply chain managers

QC and analytical methods scientists and managers

QA directors, managers and personnel

Purchasing and Materials Control managers

GMP site personnel

Senior managers of companies using CMOs

People investing in FDA-regulated product development projects

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299