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.

This webinar is a must for GMP facilities or facilities trying to be GMP compliant irrespective of the kind of product manufactured: drug, biologic, diagnostic kit, medical device or dietary supplements. This presentation will help you understand the current requirements for raw material management with tips about practical implementation. We would discuss the 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. Attendees will be able to use the training to evaluate existing programs and get tips about assuring compliance with FDA requirements. Impact on compliance with other regulatory requirements in other parts of the World will also be discussed.

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

Speaker Profile:
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products.