Wednesday, April 9, 2014

GMP Trainers - Ensure That They Are Qualified Individuals

GMP trainers must be "qualified individuals," according to 21 CFR 211 Subpart B.

Do you want to make sure your GMP trainers are qualified?

If you said yes, then consider this highly recommended course:
CGMP/QSR Trainer Certification Program - May 5-9, 2014 - Public Seminar in Fort Lauderdale, FL

Reference:  21 CFR 211 Subpart B:
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart B--Organization and Personnel
Sec. 211.25 Personnel qualifications.
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

You might also be interested in:
GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL
Surviving An FDA Inspection - a GMP Training Course

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