Best-selling cGMP/Regulatory/Compliance Training CDs for the Microbiology Lab

ComplianceOnline has created these trainings individually through world renowned experts and combined together to create a comprehensive course for companies to train their employees. You can store it as a library material and train all your employees in these compliance issues to get them ready for facing any kinds of compliance challenges and overcome it through expert advice and best practices.

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All Modules:

Module 1: Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Module 2: Conducting a risk assessment for objectionable microorganisms
Module 3: Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities
Module 4: Microbiological Risk - Do I Really Need to Test Raw Materials for Microorganisms?
Module 5: Objectionable Microorganisms in an Aseptic Environment
Module 6: Objectionable Microorganisms - Considering the Risk
Module 7: Practical Aspects of Aseptic Processing
Module 8: A Practical Approach to Microbial Data Deviation Investigations
Module 9: Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations
Module 10: Validating Disinfectants for Pharmaceutical and Biotech Operations

Module 1 : Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

Areas Covered:

• Overview of Microbiological Wellness and Thinking Like a Bug.
• Why should I Think Like a Bug?
• How do I Think Like a Bug?
• How does Thinking Like a Bug help me become cGMP compliant?
• How do I apply the concept to the regulations?
• Specific actions to take on various sections of the regulations.
• How can I save money by Thinking Like a Bug?

Module 2 : Conducting a risk assessment for objectionable microorganisms

Areas Covered:

• Definition of an objectionable microorganism.
• The difference between pathogenic and objectionable microorganisms.
• The risk if an organism is found in a raw material.
• The risk if an organism is found in the environment.
• The risk if an organism is found in a sterile environment.
• The risk if an organism is found in a product.
• Factors to consider when conducting a risk assessment
  • Potential risk from the organism, risk to the product, from the manufacturing process.
  • Potential risk from the route of administration, from the patient population, from biofilm.
  • Potential risk to products on the market, risk from customer complaints, risk from adverse events.
  • Propagation study
• Examples will be given on
  • Oral dosage facility
  • Aseptic processing facility
• Product Safety and Quality.

Module 3 : Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities

Areas Covered:

• Overview of Microbiological Integrity.
• Expectations of cGMPs.
• Microbial Integrity: Cleanliness.
• Microbial Integrity: People.
• Microbial Integrity: Training.
• Microbial Integrity: Compliance.
• Case Studies.
• Specific actions to ensure microbiological integrity.
• Making microbial integrity pay for you.

Module 4 : Microbiological Risk - Do I Really Need to Test Raw Materials for Microorganisms?

Areas Covered:

• How manufacturing processes eradicate microbes.
• Why some microbes escape the manufacturing process.
• Some really bad microorganisms.
• A changing population.
• Recent recalls and their disastrous consequences.
• The true cost of cost reductions.
• Questions.

Module 5: Objectionable Microorganisms in an Aseptic Environment

Areas Covered:

• What does aseptic mean?
• How do I make my plant aseptic?
• What is an Objectionable Microbe?
• What's the risk if I find an OM?
• How do I conduct a risk assessment?
• Examples.
• Questions.

Module 6 : Objectionable Microorganisms - Considering the Risk

Areas Covered:

• What is an Objectionable Microbe?
• Pathogens vs. Objectionables.
• Just how objectionable is it?
• Consider the risk.
• Performing a risk assessment.
• Example.

Module 7 : Practical Aspects of Aseptic Processing

Areas Covered:

• Overview of the FDA Guidance document Sterile Drug Products Produced by Aseptic Processing including associated cGMPs.
• Training - the most important component.
• Buildings and Facilities.
• Components and Container Closure.
• Validation and Sterilization.
• Laboratory Controls.
• Blow Fill Seal Technology.
• Documentation.

Module 8 : A Practical Approach to Microbial Data Deviation Investigations

Areas Covered:

• What guidance documents govern microbiological data deviations (MDD)?
• What should we do about the specific batch and related batches of products when an MDD is found?
• What is the difference between an objectionable microorganism and one that is pathogenic?
• How do I determine the root cause?
• How do I conduct a microbiological risk assessment?
• How do I determine a corrective and/or preventative action?
• How to I demonstrate that the corrective/preventive action was effective?
• What can I do to minimize the reappearance of the excursion?

Module 9 : Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Operations

Areas Covered:

• Review data from “real-world” examples.
• Learn how to develop solutions to your microbial control problems.
• This seminar focuses on both preventative measures and corrective actions.
• This session will be interactive with audience input.

Module 10 : Validating Disinfectants for Pharmaceutical and Biotech Operations

Areas Covered:

• Learn disinfectant testing methodologies.
• Review “real world” examples of disinfectant efficacy tests.
• Increase awareness of pitfalls encountered during testing.
• Troubleshooting problems related to disinfectant efficacy testing.
• Examples of disinfectant validation successes will be discussed.

Who Will Benefit?

These trainings will provide valuable assistance to all FDA and EMEA regulated companies, including companies in the Pharmaceutical, Biotech, and Medical Device fields. The employees who will benefit include:

• Senior management and laboratory personnel responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/process development
• Microbiology, Quality Control, Quality Assurance, Manufacturing, Validation, Regulatory Affairs, R&D, Discovery, Finance
• Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
• Senior executives
• Regulatory and Compliance Management
• Audit professionals, Validation Specialists
• Information Technology professionals
• Research and Development
• Disinfectant Validation Managers
• Cleanroom Managers
• Personnel and contractors that clean and disinfect cleanrooms
• Environmental Monitoring Managers

Instructor Profiles:

(Modules 1 - 9)

Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and startup companies with the essential advice they need to keep their businesses running efficiently and within regulatory guidelines.

With over 30 years of pharmaceutical business, manufacturing and laboratory experience he is an authority on FDA Warning Letters and 483s, GMP compliance, validation planning, outsourcing, microbiology, sterile and non-sterile manufacturing issues. His accomplishments in science (setting up and running laboratories), compliance (auditing, validation, and outsourcing) and business (building a start-up pharmaceutical company and its infrastructure) endow him with a unique over site of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.

(Modules 10)  

Jim Polarine, is a technical service specialist at STERIS Corporation. He has been with STERIS Corporation for over eight years, where his current technical focus is microbial control in Cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, Latin America, and Puerto Rico on issues related to disinfection and sanitation in Cleanrooms.

Mr. Polarine is a frequent industry speaker and has worked on several book article publications related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is an author on the PDA technical report on cleaning and disinfection. He is also currently active on the PDA task force on cleaning and disinfection. He has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee, SWE, and Barnett International on cleaning and disinfection and contamination control.

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