ComplianceOnline

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed. The various regulatory bodies’ requirements such as 21 CFR Part 211 (mostly relevant 211.113 “Control of microbiological contamination”, ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice”) amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products.

The seminar will consist of two (2) Parts for a total of 6 Modules.

There are seven (7) key topics that will be discussed on Day 1 and Day 2 of the Seminar are as follows:

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
  • Cleanroom Regulations, Classifications, Basic Background and Design Considerations
  • Cleanroom Qualification, Cleaning Validation (IOQ/PQ), Routine Monitoring and Excursion Investigation
  • Environmental Monitoring Program (Monitoring, Excursion Investigation and Trending of Data)
  • Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures)
  • Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy)
  • Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program
  • Basics of Sterilization Processes- Physical and Chemical Processes

Bonus:Compliance Expectations, FDA Form 483’s and Case Studies

Learning Objectives:

  • Discuss Cleanroom Classification, Regulations and Guidelines
  • Summarize how to Perform Cleanroom Design, Validation/Qualification, Operation, Environmental Monitoring Program and ensuring a state of control
  • Describe Aseptic Practices, Personnel Health Practices, Gowning and Trafficking Patterns in a Cleanroom
  • Establish and describe the Requirements of Cleanroom Cleaning/Disinfection and Contamination Control Practices
  • Summarize various Sterilization Processes, Advantages and Disadvantages –both Physical and Chemical
  • Describe the Sterilization Processes and Controls

Who will Benefit:

This training will benefit those involved in the manufacturing, processing, testing and release of sterile and non-sterile products. It will provide the attendee an understanding of the basic concept of microbiology, microbiological and contamination control practices, cleanroom design, routine testing, qualification/validation and use of cleanrooms as well as the typical sterilization processes (Physical and Chemical) within various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries, especially personnel and management in:

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Validation
  • Supplier Quality Assurance
  • Regulatory Affairs
  • Shipping and Receiving
  • Facility and Maintenance
  • Engineering
  • Materials Management
  • Analysts
  • Analytical Chemists
  • All levels of management
  • Microbiologists
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Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Breakfast and introduction
  • 9:00 AM – 11:00 AM: Module 1
    • Cleanroom Guidelines, Regulations and Definitions
    • Summary of Key Areas of Cleanroom Technology and Classifications
    • Define the EU, ISO and USP Recommended Limits for Microbial Contamination
    • Cleanroom Design and Initial Design Considerations
    • Cleanroom Design Guidelines - Facility Layout, Airlocks or Anteroom, Windows and Speaking Diaphragms, Pass-through and Gowning Rooms
    • Cleanroom Design Guidelines - Cleanroom Location, Make-up Air, Cleanroom Walls- Seamless, Non-porous Surface
  • 11:00 AM – 11:15 AM: Break
  • 11:15 AM – 12.00 PM: Module 2
    • Review Cleanroom Design Guidelines (Material of Construction for Cleanroom Ceilings), Cleanroom Doors and Cleanroom Floors
    • Discuss the Design Guidelines (HVAC & Filtration Systems) and the types of Cleanroom Airflow
  • 12:00 PM – 01:00 PM: Lunch Break
  • 01:00 PM – 02.30 PM: Module 2
    • Summary of the principles and regulations guiding Cleanroom Validation (OQ/PQ) and Operation testing
    • Performing Cleanroom Effectiveness Verification Tests and utilizing Cleanroom Cleaning Validation Data in a PQ Process
    • Designing a Cleanroom Performance Qualification (PQ) Protocol and Report
    • Applying the Fundamentals of Environmental Monitoring (EM) Program, Limits, Requirements, Excursion Investigation and Data Trending
    • Perform a correlation between Contamination Control and Environmental Monitoring
    • Understand the Causes of Adverse Trends
  • 02:30 PM – 02:45 PM: Break
  • 02:45 PM – 04.00 PM: Module 3
    • How to Use the principles of Aseptic Practice regulation to set up an Aseptic Environment and for the manufacturing of a product
    • Cleanroom Practices - Personnel Health and Cleanliness, Personnel Practices (Sterile Gloves, Sterile Gowns and Operator Technique)
    • Step-wise approach in performing workstation and Equipment Cleaning and Disinfection
    • Process flow/Trafficking Patterns for Equipment, Materials, Personnel, Supplies and Waste within a Cleanroom
  • 04:00 PM – 05.00 PM: Question and Answers
Day 02(8:30 AM - 5:00 PM)
  • 08:30 AM – 09:00 AM: Breakfast
  • 09:00 AM – 11.00 AM: Module 1
    • Cleaning/Disinfection Program Guidance and Regulations
    • The Basics of Microbiology and Contamination Control and Mitigation
    • GMP Cleanroom Cleaning and Primary Cleanroom Contaminants
    • Cleanroom Gowning Guide, Garment Recommendations, Gowning/Degowning and Requirements by ISO Classification
  • 11:00 AM – 11:15 AM: Break
  • 11:15 AM – 12.00 PM: Module 2
    • Sterilization Processes and Methods (Physical and Chemical)
    • Terminologies and factors influencing Thermal (Heat) Sterilization
    • Examples of Dry Heat Sterilization (Hot air oven, Flaming (AKA Red Hot Sterilization), Incineration, Dry Heat Tunnels, Infra-red Radiation
    • Moist Heat Sterilization and Examples - Pasteurization, Boiling, Tyndallization, Autoclave/Steam Sterilizer.
  • 12:00 PM – 01:00 PM: Lunch Break
  • 01:00 PM – 02.30 PM: Module 2
    • Advantages and Disadvantages of various types of dry heat and moist heat sterilization processes
    • How to Differentiate between Ionizing and non-ionizing Radiation including microwave Radiation, Ultraviolet Radiation, Gamma Rays/Gamma Sterilization
    • Use and Disadvantages of Ionizing Radiation-Gamma Radiation
    • Chemical Sterilization Methods using various types of liquid sterilants such as Phenolic , Hydrogen Peroxide, Halogens, Chlorine and Alcohols, Heavy Metals, Quatenary, Peroxygens and Aldehydes
  • 02:30 PM – 02:45 PM: Break
  • 02:45 PM – 03.45 PM: Module 3
    • Chemical Sterilization using Gaseous Method such as Ethylene Oxide, Formaldehyde and Glutaraldehyde Sterilization
    • Sterilization by Filtration and various types of Filters
    • Monitoring of Sterilization Processes using Mechanical and internal chemical Indicators
    • Routine Monitoring of Steam Sterilizers and Ethylene Oxide Sterilizers - Bowie Dick Type Tests and Test Results
    • Installation & Repair Testing and Sterilization Process Monitors
  • 03:45 PM – 04.45 PM: Review of case studies
  • 04:45 PM – 05.00 PM: Question and Answers
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Charity Ogunsanya

Charity Ogunsanya
CEO and Founder, Pharmabiodevice Consulting LLC

Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.

She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and other regulatory bodies’ inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies’ inspections, re-inspections and new product approvals.

Her technical expertise covers and goes beyond interpretation, administration and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations.

She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections.

She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.

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$1,799.00

Seminar One Registration

December 5-6, 2019, Philadelphia, PA
(Registrations till October 5, 2019 - $1799)
(Registrations after October 5, 2019 - $1999)




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; tea/coffee and lunch on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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Location:

Philadelphia, PA
(Venue to be announced shortly)

December 5-6, 2019

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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Local Attractions of Philadelphia, PA

Philadelphia Museum of Art

Philadelphia Museum of Art

The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.
Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

Valley Forge National Historical Park

Valley Forge National Historical Park

With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.
The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell Center

The Liberty Bell Center

The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

National Constitution Center

National Constitution Center

The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

The Franklin Institute

The Franklin Institute

An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.
Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

The Barnes Foundation

The Barnes Foundation

The Barnes Foundation was created in 1922, a school originating with Barnes’ educational experimentation in his Argyrol (pharmaceutical) factory. Barnes and The Foundation’s first director of education, John Dewey, were interested in fostering cognitive development through new approaches to education, and in heightening critical-thinking and problem-solving skills through the study of art. Barnes, like Dewey, was actively engaged in development of an intellectual framework and educational philosophies and practices with many of the best artists and thinkers of his day.

The Rocky Statue

The Rocky Statue

One of Philadelphia’s most famous pieces of public art is a bigger-than-life boxer… literally. Originally created for Rocky III, the sculpture is now a real-life monument to a celluloid hero. The fictional Rocky Balboa of Sylvester Stallone’s Rocky movies was immortalized in bronze in 1980. After filming for the movie completed, Stallone donated the statue to the City of Philadelphia.

Franklin Square

Franklin Square

Franklin Square, one of Philadelphia’s five original public squares laid out by William Penn in his original plan for the city, has undergone a dramatic renovation. The park now boasts several family-friendly attractions, including a miniature golf course, classic carousel, burger joint, storytelling bench, picnic area and more.

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