The Complete Good Manufacturing Practices (GMP) Course

سرفصل های دوره

Master GMP Essentials: Quality, Compliance, Excellence

1 - Introduction

1 - WHAT ARE CGMPs

2 - THE MEANING OF CURRENT

3 - SPECIFIC DRUG CATEGORIES AND TOPICS

2 - Quality Management Systems and Risk Management

4 - Quality Management Systems and Risk Management

5 - KEY PROCESSSYSTEMS ELEMENTS

6 - QUALITY RISK MANAGEMENT

3 - Management Responsibility and Control

7 - Management Responsibility and Control

8 - THE QUALITY MANAGEMENT TRIAD MODEL

4 - RESPONSIBILITIES OF QUALITY CONTROL UNIT

9 - RESPONSIBILITIES OF QUALITY CONTROL UNIT

10 - WARNING LETTER CITATIONS SPECIFICALLY FOR THE QCU

11 - EXPECTATIONS FOR TRAINING AND TRAINING SYSTEMS IN A GMP ENVIRONMENT

12 - Curricula

13 - Training Plans

14 - Instructional Design

15 - Qualified Trainers

16 - Records

17 - CONTRACTORS AND CONSULTANTS

5 - Finished Pharmaceuticals General Provisions

18 - DIETARY SUPPLEMENTS

19 - HOMEOPATHIC DRUGS

6 - Production and Process Controls

20 - WRITTEN PROCEDURES DEVIATIONS

21 - CHARGEIN OF COMPONENTS

22 - EQUIPMENT IDENTIFICATION

23 - TIME LIMITATIONS ON PRODUCTION

24 - VALIDATION OF ASEPTIC PROCESSING

25 - VALIDATION OF ETHYLENE OXIDE STERILIZATION

7 - Records and Reports

26 - Records and Reports

27 - EQUIPMENT CLEANING AND USE LOG

28 - BATCH PRODUCTION AND CONTROL RECORDS

29 - EVENTS DEVIATIONS AND INVESTIGATIONS

30 - DETAILS AND MORE DETAILS

31 - DISTRIBUTION RECORDS

8 - Clinical Trial Supplies

32 - INTRODUCTION

33 - APPLICATION OF A CGMP CONCEPTUAL MODEL TO CTM PRODUCTION

34 - EQUIPMENT

9 - Contracting and Outsourcing

35 - Contracting and Outsourcing

36 - OUTSOURCING PROCESS

37 - OTHER TYPES OF CONTRACTORS

10 - DESIGN AND CONSTRUCTION FEATURES

38 - DESIGN AND CONSTRUCTION FEATURES

39 - LIGHTING

40 - SANITATION

11 - Equipment

41 - INTRODUCTION

42 - MAINTENANCE AND CALIBRATION PROGRAMS

43 - CALIBRATION PROGRAMS

44 - AUTOMATIC MECHANICAL AND ELECTRONIC EQUIPMENT

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