TRAINING PROGRAM

FDA 21 CFR PART 211 Subpart B-K  PHARMACEUTICALS 

Course ID: DPR0021 21 CFR Part 211: Good Manufacturing Practice Professional Certification Program 

Course ID: DPR0121 GMP: 21 CFR Part 211 Subpart B - Organization and Personnel 

Course ID: DPR0221 GMP: 21 CFR Part 211 Subpart C - Building and Facilities 

Course ID: DPR0321 GMP: 21 CFR Part 211 Subpart D - Equipment 

Course ID: DPR0421 GMP: 21 CFR Part 211 Subpart E - Control of Components, Drug Product Containers and Closures 

Course ID: DPR0521 GMP: 21 CFR Part 211 Subpart F - Production and Process Controls 

Course ID: DPR0621 GMP: 21 CFR Part 211 Subpart G - Packaging and Labeling Control 

Course ID: DPR0721 GMP: 21 CFR Part 211 Subpart H - Holding and Distribution 

Course ID: DPR0821 GMP: 21 CFR Part 211 Subpart J - Records and Reports 

Course ID: DPR0921 GMP: 21 CFR Part 211 Subpart K - Returned and Salvaged Drug Products 

FDA 21 CFR PART 820 Subpart A-O MEDICAL DEVICES

Course ID: MDR0021 Medical Device cGMP Subpart A-O Professional Certification Program 

Course ID: MDR0121   GMP: 21 CFR Part 820 Subpart A - General Provisions 

Course ID: MDR0221 GMP: 21 CFR Part 820 Subpart B - Quality System Requirements (QSR)  

Course ID: MDR0321 GMP: 21 CFR Part 820 Subpart C - Design Controls 

Course ID: MDR0421 GMP: 21 CFR Part 820 Subpart D - Document Controls 

Course ID: MDR0521 GMP: 21 CFR Part 820 Subpart E - Purchasing Controls 

Course ID: MDR0621 GMP: 21 CFR Part 820 Subpart F - Identification and Traceability 

Course ID: MDR0721 GMP: 21 CFR Part 820 Subpart G - Production and Process Controls  

Course ID: MDR0821 GMP: 21 CFR Part 820 Subpart H - Acceptance Activities 

Course ID: MDR0921 GMP: 21 CFR Part 820 Subpart I  - Nonconforming Products 

Course ID: MDR1021 GMP: 21 CFR Part 820 Subpart J  - Corrective and Preventive Action 

Course ID: MDR1121 GMP: 21 CFR Part 820 Subpart K - Labeling and Packaging Control 

Course ID: MDR1221 GMP: 21 CFR Part 820 Subpart L - Handling, Storage, Distribution and Installation 

Course ID: MDR1321 GMP: 21 CFR Part 820 Subpart M- Records  

Course ID: MDR1421 GMP: 21 CFR Part 820 Subpart N- Servicing 

Course ID: MDR1521 GMP: 21 CFR Part 820 Subpart O - Statistical Techniques 

21 CFR PART 11 ELECTRONIC RECORDS

Course ID: ESR0021 21 CFR Part 11 - Electronic Records & Signatures Professional Certification

DATA INTEGRITY & GDocP

Course ID: DIR0021 Data Integrity Professional Certification Program

Course ID: DIR0121 Good Documentation Practices (GDocP) Professional Certification 

Course ID: DIR0221 Data Integrity: Good Documentation Practice (GDocP) 

Course ID: DIR0321 GDocP: Good Documentation Practices - General Rules of Data Integrity 

Course ID: DIR0421 Data Integrity: ALCOA and ALCOA+ 

Course ID: DIR0521 Data Integrity: Computer System Validation (CSV) Best Practices

Course ID: DIR0621   Data Integrity: Data Governance 

Course ID: DIR0721 GDocP: Good Documentation Practices and Data Integrity 

Course ID: DIR0821 GDocP: Good Documentation Practices - Making Correction to Ensure Data Integrity 

Course ID: DIR0921 GDocP: Good Documentation Practices - Logbook Data Integrity 

Course ID: DIR1021 GDocP: Good Documentation Practices - Data Integrity for General Test Results 

Course ID: DIR1121 GDocP: Corrective Actions and Preventive Actions (CAPA) 

Course ID: DIR1221 GDocP: How to Write Effective Standard Operating Procedures (SOPs) 

Course ID: DIR1321 GDocP: How to Write an Effective Equipment User Requirement Specification (URS) 

Course ID: DIR1421 GDocP: Deviations management in a GMP Environment