Pacific Rim Consulting, Inc. - NEWSLETTER

Volume 13 Issue 2 - Page 3 - Fall/Summer2010

FDA To Conduct Inspections Focusing on 21
CFR 11 (Part 11) requirements relating to human
drugs

Announcement

The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.

Background

21 CFR 11 (Part 11) is the regulation that sets forth the criteria under which the Agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This regulation, which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health.

After Part 11 became effective in August 1997, significant discussions ensued among industry, contractors, and the Agency concerning the interpretation and implementation of the regulations. In response to Agency’s communications, some within industry raised concerns that interpretations of the Part 11 requirements could:

Unnecessarily restrict the use of electronic technology in a manner
that is inconsistent with FDA's stated intent in issuing the rule.
Significantly increase the costs of compliance to an extent that was
not contemplated at the time the rule was drafted.
Discourage innovation and technological advances without
providing a significant public health benefit.

In an effort to address concerns that were raised, in August of 2003 the Agency published the ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance. The guidance describes how FDA intends to exercise enforcement discretion and sets forth the following considerations related to Part 11:

Part 11 remains in effect since the issuance of the guidance and the exercise of enforcement discretion applies as identified in the guidance.
The guidance sets out certain conditions related to the validation, audit trail, record retention, record copying, and legacy systems where the Agency does not intend to take enforcement action to enforce compliance. Conversely, violations of part 11 requirements that do not fall within the guidance’s discretion can lead to enforcement action to enforce compliance depending on the importance of the violation.
Records must also be maintained or submitted in accordance with regulatory requirements outside of Part 11, and we will enforce all predicate rule requirements, including predicate rule record and recordkeeping requirements.

WCQTI provides a practical, scientific approach to Good Laboratory Practice Regulations, focusing on industry standards and common sense as well as the written code. Training materials are over 500 pages (double sided) and include numerous forms, SOPs, reference articles, and other material critical to interpreting the intent of the regulations. Courses are structured to be highly interactive, providing opportunities for workshops and discussions. Every effort is made to present subjects in an informative, energetic manner. Additional experts in their particular field are brought in periodically for certain courses.

ABOUT THE DIRECTOR

Ms. Deborah Eyer Garvin, Director of the West Coast Quality Training Institute earned her MS in Agriculture from New Mexico State University. Ms. Garvin is also President of Pacific Rim Consulting, a Quality Assurance firm specializing in consulting and auditing for FDA, EPA and OECD GLPs as well as FDA GCPs for Target Animal studies. She provides contract QA services and training to Sponsor Companies, Project Management groups, Contract Laboratories, Universities, Teaching Hospitals, and individual test sites. Coming from a contract laboratory background, Ms. Garvin has implemented GLP compliance programs at several facilities, and understands the practical aspects of GLP compliance and adherence. Constant involvement in auditing and inspecting provides unique insights regarding current problems and issues, as well as cost-effective means of compliance. Numerous professional organizations have utilized her expertise as a consultant and invited speaker. Active in the Society of Quality Assurance, Debi is a Past President of the National organization, past chair of the SQA Registration Examination Committee, and was an original member of the Professional Certification Committee. She represented the Society of Quality Assurance at the OECD workshop held in the UK regarding multi-site studies, represented the FDA at the 2008 OECD GLP Harmonization workshop, and serves on the editorial board of the QA Journal. She is also a member of the SQA FDA Modernization of GLPs task force.

Seminars offered by WCQTI (not all seminars are offered every year, but all are offered for in-house training)

One Day Seminars

GLPs 101 (an Introduction)
GLP Essentials for Technical Staff
SOPs 101

Two Day Seminars

QA Audits, Inspections and Responsibilities
GLPs in the Real World
GLPs for Scientists and Technical Staff
Application of GLPs to Field Studies
GCPs/GLPs in Target Animal Studies
GLPs in Medical Devices
Application of GLPs in the Bioanalytical Lab
GLPs for Study Directors and Monitors

ON SITE TRAINING