1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

Documentation
- Meeting the Regulatory Expectations -

A 2-Day Intensive Continuing Education Course 1.35 CEU's)

About this course:

A rugged documentation system is of pivotal importance to a company because it supports various important functions. It provides unequivocal legal proof that work was adequately planned and performed on claimed dates, it helps in the trouble-shooting of technical and managerial problems, it facilitates company growth and technology transfer, it provides a written history of company and products, and it proves to regulators that the company follows its commitments.
To fulfill these functions documents must be clear, comprehensive, not overlapping in their content, authentic, falsification resistant and must cover all important aspects in sufficient detail.

In spite of its obvious importance to companies and regulators, inadequate or inappropriate documentation ranks high on the list of objectionable findings of inspectors during pre-licensing and regular GMP inspections.

This course teaches how to set up or augment an existing documentation system and how to appropriately document commitments, procedures and work to comply with current GLP and GMP regulations.

YOU WILL BENEFIT FROM THIS COURSE…

• if you belong to

  • Quality Assurance or Quality Control

  • Research and Development

  • Process Development

  • Manufacturing

  • Validation

  • Regulatory Compliance

• if you

  • design documentation systems

  • write or review

    • standard operating procedures

    • policies

    • protocols

    • reports

    • plans

• if you simply need a better understanding of proper, state-of-the-art documentation that meets regulatory expectations, enables technology transfer and withstands courtroom attacks

THIS COURSE WILL IMPROVE YOUR KNOWLEDGE OF...

• how to use, maintain and review research notebooks

• how to adequately document studies performed under GLP regulation

• how to set up a comprehensive and efficient , yet economical, GMP-conforming documentation system

• how to control your company's documentation system

• what needs to be documented

• how to write

  • policies

  • plans

  • specification records

  • standard operating procedures

  • master batch records

  • validation protocols

  • reports

• how to adequately record data in

  • logbooks

  • data collection forms

  • batch records

  • QC records

  • validation records

• the required elements of electronic documentation systems