Webinar on Prepare for Your cGMP Inspection

This webinar will focus on the U.S. FDA's FY 2013 cGMP audit issues, recent guidance documents and stated 2014 initiatives.

Areas Covered in the Session :

Industry trends

Recent FDA actions / FY 2013 483 observations

The FDA's recently instituted annual "Strategic Priorities" initiative

Emphasis on 2014, and future issues

A review focusing on the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system / CGMP compliance

An additional review of recent information from the Agency

Other goals of the Agency that have already been translated into action

Further direction in areas of concern and what to expect in the future

Process validation

Wireless device guidance

The new UDI initiative and counterfitting concerns

The global supply chain, lifecycle, combo products, "better" science, and expanding "risk based" applications

Who Will Benefit:

This webinar will provide valuable information to all regulated in reviewing and modifying their regulatory complaince stance. Its principles apply to Personnel / Companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

Senior management

Middle management

Research & Development

Engineering

Software

QA / RA

Manufacturing

Operators

Consultants

cGMP Instructors

Verification and/or Validation Planning Teams

Execution and Documentation Teams

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