GXP Training and Guidance from Center for GMP, India

Contamination Control & Biosafety

Basics of integrated microcontamination control

Course Title	Basics of integrated microcontamination control
Course Reference Code	Module CC-01
Course Pre-requisite	None
Course Content	Introduction Understanding contaminants Aerosol characteristics Understanding the microcontamination process Master microcontamination control plan
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge and skills to contribute effectively to the upkeep of controlled microenvironments, with particular motivation to experiment with incremental changes for operational improvements.
Target Audience	Operators, Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	2 hours

ISO 14644 family of standards for cleanrooms and their implementation

Course Title	ISO 14644 family of standards for cleanrooms and their implementation
Course Reference Code	Module CC-02
Course Pre-requisite	None
Course Content	Review of the evolution of cleanroom standards ISO 14644 Part 1 Comparison with US & European standards it has superseded Interpreting the provisions Implications to the User ISO 14644 Part 2 Interpreting the provisions ISO 14644 Part 3 Interpreting the provisions ISO 14644 Part 4 ISO 14698 Parts 1,2 and 3
Learning Objectives	At the end of the course, participants will have acquired sufficient insights into the new standards to contribute effectively to the design, installation, testing and maintenance of controlled microenvironments, with particular motivation to upgrade their facilities and SOPs to bring them in line with current ISO requirements.
Suggested Target Audience	Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	4 hours

Understanding Drug & Devices Regulatory Expectations for cleanrooms and their implementation

Course Title	Understanding Drug & Devices Regulatory Expectations for cleanrooms and their implementation
Course Reference Code	Module GMP-04
Course Pre-requisite	None
Course Content	Review of the evolution of Drug & Devices cleanroom standards EUGGMP, WHO, Schedule (M) & USFDA Interpreting the provisions Implications to the User
Learning Objectives	At the end of the course, participants will have acquired sufficient insights into the Drug & Devices Regulatory Expectations for cleanrooms to contribute effectively to the design, installation, testing and maintenance of controlled microenvironments, with particular motivation to upgrade their facilities and SOPs to bring them in line with current requirements.
Suggested Target Audience	Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	2 hours

Understanding air filters

Course Title	Understanding air filters
Course Reference Code	Module CC-03
Course Pre-requisite	None
Course Content	Air filter nomenclature Air filter classification Types of air filters and how they work Various filter configurations and their merits and de-merits Understanding the HEPA and ULPA filters Limitations of HEPA/ULPA filters Intelligent use of HEPA and ULPA filters Important miscellania about HEPA and ULPA filters Replacement and handling of filters in Biohazard/Radiological environs Static charge control Electronic air filters Chemical filters Dehumidification Cascade filtration
Learning Objectives	At the end of the course, participants will not only have learned about air filters and their mechanisms, but also will appreciate what these filters can do and , more importantly, what they cannot do. They will be better informed about what to specify and order, and how to discriminate between competing vendors and brands.
Suggested Target Audience	Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	2 hours

Elements of cleanroom design engineering

Course Title	Elements of cleanroom design engineering
Course Reference Code	Module CC-04
Course Pre-requisite	Modules CC-01, CC-02 (or GMP-04) and CC-03
Course Content	Premises: Cleanroom Shell Considerations in Selection of location & layout Cleanroom construction & interior finishes Points to ponder in cleanroom design Specifying the HVAC & filtration system Selection of air cleanliness class Selection of airflow pattern - Uniform flow, Mixed or Turbulent Overpressure considerations Other relevant points to ponder Modular prefab cleanrooms Isolators & other barrier technologies
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge and skills to contribute effectively to the design, installation and maintenance of controlled microenvironments, with particular motivation to experiment with incremental changes for major improvements.
Suggested Target Audience	Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	4 hours

Qualification of controlled environments: Testing & Certification

Course Title	Qualification of controlled environments: Testing & Certification
Course Reference Code	Module CC-05
Course Pre-requisite	Module CC-03
Course Content	Drawing up a qualification programme in line with appropriate Standard/Guideline Test parameters, apparatus and methods Challenge Aerosols Aerosol penetration Photometers Performance & integrity testing of HEPA/ULPA filters Optics of sub-micronic particles Airborne Particle Counters Uncertainties in testing On-line Vs Off-line monitoring Biological Monitoring Airflow visualisation Other parametric tests
Learning Objectives	At the end of the course, participants will have gained sufficient appreciation of environmental qualification to draw up SOPs meeting current compendial requirements, and will be better placed to ensure that the testing and certification process, whether executed in-house or through some external agency, is indeed in accordance with the norms prescribed by governing standards .
Suggested Target Audience	Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	2 hours

Understanding the adverse impact of the human interface in Cleanroom

Course Title	Understanding the adverse impact of the human interface in Cleanrooms
Course Reference Code	Module CC-06
Course Pre-requisite	Module CC-01
Course Content	Human microenvironment Intrinsic contaminants Extrinsic contaminants Visualising the interaction of the human microenvironment on cleanroom airflow fields Importance of Personal hygiene and decontamination Importance of Bioprofiling of cleanroom operators Contamination control clothing Good Gowning Practice Cleanroom laundry Good conduct and comportment
Learning Objectives	At the end of the course, participants will have gained sufficient appreciation of the adverse effects they can bring to play in controlled environments and the microcontamination process, and will be better prepared to formulate and comply with stringent SOPs for decontamination, gowning and behavioural practices.
Suggested Target Audience	Operators, Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	2 hours

Cleaning, sterilisation & disinfection of Cleanrooms

Course Title	Cleaning, sterilisation & disinfection of Cleanrooms
Course Reference Code	Module CC-07
Course Pre-requisite	Modules CC-01 and CC-06
Course Content	Understanding cleanroom soil Discriminating among gross cleaning, precision cleaning and cleansing Sterilisation: an overview Golden rules of Good Sanitation Practice Criteria for selecting cleaning agents Drawing up a Sanitation Programme Verification of the cleaning process Tracing the origins of soil Criteria for selection of disinfectants Use and abuse of disinfectants Environment disinfection
Learning Objectives	At the end of the course, participants will have acquired adequate knowledge to carry out an audit of their current practices and draw up revised SOPs that address the loop-holes that may have been existing and bring about qualitative improvements in their sanitation programme with judiciously selection and optimal use of appropriate cleaning and disinfecting agents.
Suggested Target Audience	Operators, Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	2 hours

Selection, function and use of Laminar airflow workstations

Course Title	Selection, function and use of Laminar airflow workstations
Course Reference Code	Module CC-08
Course Pre-requisite	Modules CC-01, CC-02 (or GMP-04), CC-03 and CC-06
Course Content	Understanding unidirectional (laminar) airflow Classes of air cleanliness Various LAF configurations and their merits and de-merits Partial recirculatory and other variants Selecting a configuration that meets your application needs Good Working Practice Upkeep and maintenance Testing & certification
Learning Objectives	At the end of the course, participants will have acquired sufficient information to judiciously select and optimally use the appropriate configuration and class of Controlled Environment Work Station they need, and draw up SOPs for sanitation and upkeep, and ensure that testing and certification, whether executed in-house or through some external agency, is indeed in accordance with the norms prescribed by governing standards.
Suggested Target Audience	Operators, Supervisors, Project Engineers, Maintenance Engineers, QA, R&D, GMP Personnel and end-Users
Course Duration	2 hours

Selection, function and use of biological safety cabinets (BSCs)

Course Title	Selection, function and use of biological safety cabinets (BSCs)
Course Reference Code	Module CC-09
Course Pre-requisite	Modules CC-01, CC-02 (or GMP-04), CC-03 and CC-06
Course Overview	This program presents information on the selection, function and use of biological safety cabinets (BSCs), which are the primary means of containment developed for working safely with infectious microorganisms. BSCs are only one part of an overall biosafety program, which requires consistent use of good microbiological practices. Detailed descriptions of acceptable work practices, procedures, and facilities, described as biosafety levels 1 through 4, are also presented.
Course Content	Principles of Biosafety Laboratory Biosafety Level Criteria Laboratory Hazards and Risk Assessment Primary Containment: Biological Safety Cabinets The High Efficiency Particulate Air (HEPA) Filter and the Development of Biological Containment Devices BSC Class I BSC Class II Type A BSC Class II Type B1 BSC Class II Type B2 BSC Class II Type B3 BSC Class III Good Biological Safety Practices: Work Practices and Procedures Secondary Containment: Facility and Engineering Requirements Laboratory Security and Emergency Response for Microbiological and Biomedical Laboratories Testing, certification and qualification of BSCs Use & maintenance of facilities & equipment
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge and skills to contribute effectively to the design, installation and maintenance of biologically safe microenvironments, with particular motivation to experiment with incremental changes for major improvements
Suggested Target Audience	Project Engineers, Maintenance Engineers, QA, R&D, Biosafety Personnel and end-Users.
Course Duration	4 hours

Biosafety in Microbiological and Biomedical Laboratories & production facilities

Course Title	Biosafety in Microbiological and Biomedical Laboratories & production facilities
Course Reference Code	Module CC-09
Course Pre-requisite	Modules CC-01, CC-02 (or GMP-04), CC-03 and CC-06
Course Overview	Microbiological laboratories are special, often unique work environments that may pose identifiable infectious disease risks to persons in or near them. Infections have been contracted in the laboratory throughout the history of microbiology. A number of cases were attributed to carelessness or poor technique in the handling of infectious materials. Experience has demonstrated the prudence of the Biosafety Level 1-4 practices, procedures, and facilities for manipulations of etiologic agents in laboratory settings and animal facilities. This program specifically describes combinations of microbiological practices, laboratory facilities, and safety equipment, and recommends their use in four categories or biosafety levels of laboratory operation with selected agents infectious to humans as applied in practical laboratory situations.
Course Content	Principles of Biosafety 1-2-3 of Biosafety Levels Recommended Biosafety Levels for Infectious Agents Design considerations for Biosafe Facilities Primary Containment: Biological Safety Cabinets Secondary Containment: Biologically Safe Laboratories Secondary Containment: Biologically Safe Production Facilities Good Biological Safety Practices Laboratory Security and Emergency Response for Microbiological and Biomedical Laboratories Testing, certification and qualification of BSCs Testing, certification and qualification of Biosafe Laboratory facilities Testing, certification and qualification of Biosafe Production facilities Investigation of out of specification conditions Use & maintenance of facilities & equipment
Learning Objectives	At the end of the course, participants will have acquired sufficient knowledge and skills to contribute effectively to the design, installation and maintenance of biologically safe macro- and microenvironments, with particular motivation to experiment with incremental changes for major improvements
Suggested Target Audience	Project Engineers, Maintenance Engineers, QA, R&D, Biosafety Personnel and end-Users.
Course Duration	8 hours

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