GMP Microbiology Training - Pack of 12 webinars


Training
15 Hours
Compliance Trainings
ID: 5851325

This exclusive Pack contains 12 courses:

1. ISO/IEC 17025 Update - The Latest Standard for Laboratory Competence
2. Objectionable Microorganisms in Biopharmaceutical Production - Identification and Risk Mitigation
3. Quality Control for Analytical Materials used in Microbiology Laboratories
4. Steam Sterilization Microbiology and Autoclave Performance Qualification
5. Is it Microbiological Method Verification or Validation, or Just Semantics?
6. Environmental Monitoring Investigation Techniques for Effective Contamination Control
7. Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
8. Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program
9. Aseptic Process Overview and Validation
10. Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance
11. Handling OOS Test Results and Completing Robust Investigations
12. Analytical Microbiology - Contract Lab vs In-House Lab - How to Overcome the Corporate Dilemma

Course Content

TOPIC 1: ISO/IEC 17025 Update - The Latest Standard for Laboratory Competence

Speaker:

Michael Brodsky

Duration:

60 Minutes

Have the rules changed? Recall the differences between ISO/IEC 172025:2005 and the newly revised version, ISO/IEC 17025:2017
What are the new requirements of ISO/IEC 17015:2017?
Identify the new documents and records required by the standard
How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?
Implement a quality documentation transition plan to ensure compliance with the newly revised standard
Defining a QMS
Management Components of a QMS
New and revised Quality Management Requirements
Technical Components of a QMS
New and revised Technical Requirements
Method Selection, Validation and Verification
Ensuring analytical competency
Identifying adjustments to your existing ISO/IEC 17025:2005 Quality Documentation

TOPIC 2: Objectionable Microorganisms in Biopharmaceutical Production - Identification and Risk Mitigation

Speaker:

Carl Patterson

Duration:

60 Minutes

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

TOPIC 3: Quality Control for Analytical Materials Used in Microbiology Laboratories

Speaker:

Michael Brodsky

Duration:

60 Minutes

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

TOPIC 4: Steam Sterilization Microbiology and Autoclave Performance Qualification

Speaker:

Danielle DeLucy

Duration:

75 Minutes

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

TOPIC 5: Is it Microbiological Method Verification or Validation, or Just Semantics?

Speaker:

Michael Brodsky

Duration:

60 Minutes

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

TOPIC 6: Environmental Monitoring Investigation Techniques for Effective Contamination Control

Speaker:

Carl Patterson

Duration:

60 Minutes

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

TOPIC 7: Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

Speaker:

Michael Brodsky

Duration:

60 Minutes

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

TOPIC 8: Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

Speaker:

Carl Patterson

Duration:

60 Minutes

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

TOPIC 9: Aseptic Process Overview and Validation

Speaker:

Kelly Thomas

Duration:

90 Minutes

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

TOPIC 10: Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance

Speaker:

Dr. Ludwig Huber

Duration:

75 Minutes

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.

TOPIC 11: Handling OOS Test Results and Completing Robust Investigations

Speaker:

Danielle DeLucy

Duration:

180 Minutes

Session 1: Guidelines for Detecting an OOS or Atypical Result

Definition Atypical or Out of Specification Result?
Review of the FDA Guidance for Industry on Investigating OOS Test Results
Phase I: Initial Laboratory Investigation
Phase II: Full Scale Investigation
Root Cause Analysis Methods
5 Whys
Flow Charts
Checklists
Fishbone Diagrams

Session 2: Testing the hypotheses regarding potential root causes

Retesting
Considering Other Batches

Session 3: Developing a proper CAPA plan to address any Corrective Actions

How to properly document findings
Example of a proper OOS investigation write up

TOPIC 12: Analytical Microbiology - Contract Lab vs In-House Lab - How to Overcome the Corporate Dilemma

Speaker:

Michael Brodsky

Duration:

60 Minutes

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

Speakers

Carl Patterson
Danielle DeLucy
Dr. Ludwig Huber
Kelly Thomas
Michael Brodsky

Course Content

Speakers

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