GMP Microbiology Training - Pack of 12 webinars

Agenda:

• Definition of Good Clinical Practice
• Provide a historical perspective on GCP
• Why do we need GCP?
• 13 core principles of GCP
• Introduction to ICH E6
• Review of ICH E6 (R3) Latest Guidance
• How to implement GCP in your organization

• Regulations pertaining to objectionable microorganisms
• Knowing what microorganisms are considered objectionable
• The importance of knowing what microorganism are there in your product
• Identifying objectionable microorganisms
• Sources of microorganisms in pharmaceutical manufacturing facility
• How to determine if you have an objectionable microorganism
• Tests to determine objectionable microorganisms
• Methods to control and reduce the amount of objectionable microorganisms

Agenda:

• Control Points
• Critical Control Points
• QC from purchase to disposal
• Performance Criteria
• Sterility
• Productivity
• Selectivity

• Steam sterilization on a microbial level
• IQ/OQ/PQ Requirements for Autoclave Validation
• Regulatory and GMP requirements for steam sterilization
• Autoclave Monitoring Tests
• Process verification tools for use in an autoclave
• Biological Indicators - How and When to Use
• Common questions, problems and cGMPs
• Verification vs. Revalidation

Is it Microbiological Method Verification or Validation, or Just Semantics?

• Evaluating the difference between Method validation and verification
• Method validation to establish performance characteristics
• Method Verification to establish analytical competency
• Fitness for purpose

Environmental Monitoring Investigation Techniques for Effective Contamination Control

• International Regulations (ISO)
• Federal regulation (FDA, USP)
• Contamination events
• Non-viable testing
• Viable testing
• Use of disinfectants for cleanrooms
• Possible root causes
• Identification of microorganisms

Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

• Defining the Problem
• Examining the Data
• Identifying Possible Causal Factors
• Identifying the Root Cause(s)
• Taking Corrective Action
• Verifying the effectiveness of the corrective action

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

• Introduction to current USP <85> Bacterial Endotoxin Test
• Types of Bacterial Endotoxin Test Methodologies
• Advantages and Disadvantages of Each Methodology and Choosing the Appropriate Method
• Initiating a Bacterial Endotoxin Test-Initial Considerations
• LAL Testing Materials and Reagent Qualification
• Products Receipt, Handling and Storage
• Product Processing
• Handling, Investigating and Resolving Failure and Out of Specification (OOS) Results
• Relationship of Endotoxin Test (LAL) with other Production and Process Controls

Aseptic Process Overview and Validation

• Explain the difference between Aseptic and Bulk processing
• Understand facility and personnel requirements necessary to maintain microbial control
• Explain basic principles of aseptic processing, including:
• Cleanliness classifications
• Process differences between aseptically produced and terminally sterilized product
• Relation of manufacturing and handling procedures to sources of product contamination
• Elements of a robust environmental program and why EM is important
• The role of isolator technology
• Process Validation Requirements: How to Perform a Successful Media Fill
• Process Validation Requirements: Sterile Filtration Validation

Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance

• Eight key FDA/EU requirements for integrity and security of laboratory data.
• How FDA inspectors check integrity and security of data.
• Most frequent security and integrity issues: going through recent 483’s, EIRs and warning letters?
• The importance of limited access to ‘individual users’ rather than to groups.
• FDA compliant definition, acquisition, maintenance and archiving of raw data.
• Critical integrity and security issues during the entire life of laboratory data: from data acquisition through evaluation to archiving.
• Examples how to ensure and document data integrity.
• Documenting changes of laboratory data: paper, hybrid systems, electronic.
• The importance of electronic audit trail to document data integrity.
• Review of electronic audit trail: who, what, when and how.
• Ensuring timely availability through validated back-up and archiving.
• Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

Handling OOS Test Results and Completing Robust Investigations

Analytical Microbiology - Contract Lab vs In-House Lab - How to Overcome the Corporate Dilemma

• Who is doing what
• Purpose of testing
• Organisms of concern and risk factors
• Analytical methods
• Time constraints
• Laboratory capabilities and facilities
• Laboratory accreditation and FSMA
• Analyst competency
• Cost considerations