Frankly, it had been a very long time since we last saw “failure to conduct training” or "lack of appropriate training" mentioned by the FDA in a warning letter or 483. I was just about to go and review to see if sections  CFR 820.25 / CFR 211.25  had been deleted. Maybe personnel didn’t need to know what they were doing after all!

It was during this visit to the FDA website that I  noticed a string of recent (2010) warning letters all pointing to the FDA’s renewed interested in personnel qualification. Contrary to historic warning letters that pointed to crude items such as "GMP training not taking place" or "GMP not taking place at sufficient frequency", recent warning letters seem to have developed a level of sophistication  referring to the “as they relate to the employees functions” clause.

Since the arrival of Dr. Margaret Hamburg the 20th FDA Commissioner many of us were expecting some big and bold changes. Seems lik Dr. Hamburg’s team is settling in and slowly changing the face of the agency. Early last year FDA completed the hiring of  some 1,300 new scientists, many of whom were trained as active field inspectors. The fact that the safety of the general public depends on qualified and competent quality teams who have the knowledge and authority to create "a culture of quality" within companies is begining to sink in. As a result, heads are coming out of the sand one way or the other!

The below are excerpts from a warning letter issued on 7/02/2010:

“Failure to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by 21 CFR 820 are correctly performed, as required by 21 CFR 820.25(a).“

a. The job description for the Director of Quality Systems requires that the person have a Bachelor of Science/Technical/or Engineering discipline. The person holding the position does not have this type of degree, but rather a Business Administration degree.

b. The person holding the Regulatory Affairs Manager position lacks the minimum of 5 years of regulatory experience required in the job description.

c. The person holding the Quality Control Supervisor position lacks the required Bachelor degree in science or the alternative five to eight years experience in Quality Control.

d. The person holding the Calibration Coordinator position lacks the required Bachelor degree and the four years of relevant experience."

“5. Your firm failed to conduct current good manufacturing practice (CGMP) training as related to the employees' assigned functions [21 C.F.R. § 211.25(a)]. “

Link to Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219001.htm

The below is an excerpt from a warning letter issued on 05/18/2010, seems to be a follow up inspection:

"As evidenced in prior examples, your firm has not trained your employees on CGMP regulations. We acknowledge you have established a procedure for conducting routine CGMP training and have requested a third party expert consulting firm to provide CGMP training to your employees.

You failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform their assigned functions [21 C.F.R. § 211.25(a)].

For example, your "QC/ R&D Chemist" has not been trained to perform specific tasks such as microbial limits testing under USP <61>."

Link to  Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219659.htm

Did we not provide a complete overview of the new USP <61> and USP <62> just a few months ago? I guess not everyone was paying attention, which reminds me, we have some great content upcoming I am listing some of the titles below.

Upcoming Web Training Courses:

Click on Topic to go to course abstact

The Best Approaches to Implement when Analyzing Environmental Microbiology Out-of-Specification (OOS) Data * NEW Topic!*

Good Monitoring Practices for Medical Devices * Annual Refresher*

Disinfectant Choice, Qualification and Cleanroom Contamination Control | Disinfectant Qualification Study – Planning, Execution, and Review* *2-Parts! New Topic*

Analytical Expectations in Characterization and Comparability Studies of Biotechnology Products and Emerging Biosimilars *Can't Miss Topic for Biologics*

Annual GMP Training – Canadian Regulations - 2009 GMP Edition, Changes & Interpretation *If your products find their way to Canada this is a must attend Annual Refresher*

Latin America – Understanding the Structure, Regulatory Requirements and Compliance Processes for the Pharmaceutical, Biotech and Medical Device Industries *re-scheduled by client request*

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:

1. Unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule.
2. Significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted.
3. 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.

The Agency expects to begin conducting the Part 11 focused inspections soon.