After thousands of training hours in the pharmaceutical industry, the author Anna Lund閚 has earned a good understanding for what kind of GMP knowledge that is required both for employees in this industry as well as for suppliers, consultants, and contractors in pharmaceutical industry.

Now Anna Lund閚 has gathered the most important GMP facts in one book:

• Basic knowledge about GMP in a clear and easy to read style
• Suitable for self studies and to note references of one's own practice
• Tables with detailed references to the requirements for procedures and records in both FDA and EU GMP texts and a comparison of different terms
• A unique appendix with cross-references between the GMP requirements and ISO 9001
  

Blue Bell Consulting is the sole authorized agent for Key2Compliance® products in Greater China Area.

After thousands of training hours in the Medical Device industry, Anna Lund閚 has earned a good understanding for what kind of GMP/QSR knowledge that is requested, both for the employees in this industry as well as for people in adjacent companies as suppliers, consultants and contractors.

Now Anna Lund閚 have gathered the most important facts in this book:

• Basic knowledge about GMP/QSR in a clear and easy to read style
• Comparison of similarities and differences in requirements and terminology in ISO 13485 and US QSR (21 CFR 820)
• Tables with specific references to requirements in ISO 13485 and 21 CFR 820
• Suitable for self studies and to note references to one抯 own activities

Blue Bell Consulting is the sole authorized agent for Key2Compliance® products in Greater China Area.