Your cart is empty.

Browse Categories


Search


Stay In Touch


Login



Change Control Combo

List Price: $298.00
Price: $178.95
You Save: $119.05 (40 %)
Item Number: CCCombo

Special Edition - Change Control Implementation

Topics in these nine information-packed articles include:

  • Validation and Change Control
  • The Training Side of Change Control
  • Considerations in Effectively Managing Change Control Issues
  • Characterizing Design Changes Throughout the Product Lifecycle
  • The Management of Change Control or Some Facsimile Thereof
  • Change Control FD-483 Citations ? What Went Wrong?
  • Change Control: Seven Pharmaceutical Manufacturers Share Their Experiences
  • Implementing a Medical Device Change Control Program for Computer Validation Documentation
  • Designing the Perfect Change Control System

A Practical Guide to Change Control System Management

This 42 page Technical Guide provides a step-by-step approach to implementing effective change control procedures. This exclusive Technical Guide reviews such topics as:

  • cGMP Regulations and change control
  • Change control management

Possible changes encountered in Pharmaceutical Manufacturing including:

  • Product development phase
  • Facility changes
  • Utilities changes
  • Equipment changes
  • Component changes
    Process Changes

Change Control management tools including how to address:

  • Deviations
  • Nonconforming materials control
  • Hold for release issues
  • Out-of-specifications investigations
  • Validation Change Control issues
  • Quality failure/incident investigation

Product Reviews

(1 Rating, 1 Review) Average Rating:
ratingratingratingratingrating
ratingratingratingratingrating
PJA (Unknown) 5/16/2008 6:05 AM