Managing Aseptic
Processing Operations
For Pharmaceutical, Biopharmaceutical, and Biotech
Industries
A Two Day COMPREHENSIVE & INTERACTIVE COURSE
with Workshops and Discussions On:
- GMP Guidelines and Expectations for Aseptic
Processing
- FDA Aseptic Processing Guidance; EU Annex
1 Revisions
- Avoiding Common Problems in Sterile Filtration
- How to Establish a Sterility Sampling Program
- Setting Media Fill Requirements and Acceptance
Criteria
- Conducting a Media Fill Failure Investigation
- Proper Incubation Methods and Issues
- Strategies for Investigating Sterility Failures
- Conducting Laboratory and Manufacturing OOS
Investigations
- Using Corrective and Preventative Action
Plan (CAPA)
- Cleanroom Design Criteria and Maintenance
Programs
- Personnel Training and Operator Qualification
- Equipment and Process Qualification Requirements
- Designing the Cleaning Process in an Aseptic
Environment
- Choosing Test Criteria for Markers supporting
Cleaning Validation
- Document Control for the Cleaning Process
- Effectively Auditing Aseptic Processes and
Facilities
- Vendor Selection and Documentation Requirements
Distinguished Panel of Speakers:
Dr. Carolyn Broughton
Scientist, Quality Control
Genentech
Carolyn Broughton, PhD, is currently a Scientist
in Quality Control at Genentech, Inc. She has
more than twenty years of experience managing
microbiology laboratories in the biotechnology,
pharmaceutical and cosmetics industries. She
has authored articles for professional journals,
presented at professional meetings, and provided
training at laboratory courses. She received
her PhD in Microbiology from North Carolina
State University.
Joseph Brower
Vice President
MKCS
Joseph Brower is Vice President of MKCS, Inc., a full service systems integration firm providing automation and control solutions to the pharmaceutical, industrial, and manufacturing industries. Prior to joining MKCS, he served as Plant Manager for a start-up sterile manufacturing plant in Raleigh, NC. Brower has held positions in Operations, R&D, and Technical Services for 5 sterile product manufacturers over 20 years. Mr. Brower has been involved in the procurement, testing, installation, and operation of sterile processing equipment including, vial washers, tunnels, ovens, fillers for multiple dosage forms, automated lyophilization and loading equipment, as well as equipment for support areas and utilities. Mr. Brower has a Bachelor’s Degree in biology from Kent State University in Ohio, and an MBA from Michigan State University. Brower lives Raleigh, NC.
Mr. David Vincent
CEO
Validation Technologies, Inc.
Mr. Vincent is the Chief Executive Office (CEO)
of Validation Technologies Inc. CA - USA. He
has over 23 years experience in the health care
industry with 17 years in field of validation.
Mr. Vincent expertise expands to many areas
of Quality Assurance, Regulatory Affairs and
Validation, including; eBLA submission preparation,
facility and equipment design review, process
development and validation, project management,
and utility and process equipment qualification.
He has been involved in the various aspects
of bringing many new drug manufacturing facilities
on-line, from design concept and engineering,
through construction and start-up, to the qualification/validation,
and licensing phases. He has presented many
training seminars and written many articles
regarding validation topics. Mr. Vincent teaches
"Validation Program for Pharmaceutical,
Biotechnology and Medical Device Industries
"RA 776" at San Diego State University
(SDSU) for their Regulatory Affairs Master Degree
program. Mr. Vincent has a degree in Industrial
Microbiology and Mechanical Engineering Technology.
He has been consulting for many companies nationally
and internationally.
Dr. Vivienne Yankah, CQE
Manager, Process Improvement
Sciences
Sanofi Pasteur
Dr. Vivienne Yankah is Manager, Process Improvement
Sciences at sanofi-pasteur Limited, Toronto
Canada. Her responsibilities include reviewing
and approving cleaning validation protocols
and reports, providing leadership to project/working
groups on validation studies or investigations
and developing documents for communicating the
scope and strategy of process validation and
process improvement. She holds a Ph.D degree
with specialty in Biochemistry and Biotechnology
of Lipids and was a Post-Doctoral research fellow
in the US for four years. Dr. Yankah has eight
years industry experience, is a Certified Quality
Engineer with the American Society for Quality
and has six sigma certification.
Program Content
| Day 1 |
Thursday, August 14th,
2008 |
| 8:00 AM - 8:30 AM |
Registration and
Continental Breakfast |
| 8:30 AM – 10:15 AM |
Best Practices in
Establishing Media Fill Requirements
- Define the expectation of media fills
in proving sterility assurance
- Commonly observed regulatory deficiencies
with current practices
- Media fill requirements and acceptance
criteria
- Review industry’s concerns regarding
media fills
- Discuss conditions and practices to
avoid
Management of Media Fills (Process Simulation
Runs)
- Review media fill frequency and size
of runs
- Discuss media fill durations versus
actual production lot sizes
- Discuss media fill manipulations
- Proper incubation methods and issues
- Failure investigations and corrective
actions
- Developing a compliant media fill SOP
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
Designing a Cleaning
Validation Process for Aseptic Manufacturing
Implementing Quality in Designing the
Cleaning Process
- Adherence to regulatory guidance for
cGMP : 21CFR 210 & 211
- Considerations for process capability,
consistency, and reliability
- Process parameters for robust process
design
- Personnel training for running /performing
the cleaning procedure
- Document control for the cleaning process
- Demonstrating process qualification
in accordance with the expectations of
the cleaning procedure
How to Design the Cleaning Process in
an Aseptic Environment
- Distinguish between validation and verification
- Developing the times/cycles for the
cleaning process
- Identifying "critical " areas
of cleaning procedure and equipment
- Choosing the cleaning method and agent
- Choosing the test criteria for markers
supporting cleaning validation
- Considerations for validation of test
methods used for cleaning validation samples
Executing the Cleaning Validation Process
- Types of sampling
- Choosing the sampling locations
- Deriving the acceptance criteria
- Critical background information
Maintaining the Cleaning Process
- Investigating non-conformances, out
of specification test results
- Monitoring the cleaning validation
process
- Opportunities for application of continuous
process improvement
Interactive Exercise – Case Study
|
| 12:00 PM – 1:00 PM |
Luncheon |
| 1:00 PM – 2:30 PM |
Aseptic Packaging
Process - Equipment Selection Tools
General Aseptic Flow & Processes for
Primary Packaging
- Learn the general flow for aseptic processes
- Common equipment used for aseptic process
- Differences between terminal sterilization
and aseptic technique
- Learn facility design practices for
aseptic areas
- PAT practices and future potential
PAT
Formulation & Sterilization Equipment
Selection
- Equipment used in the formulation of
aseptic products
- Sterilization equipment used for preparing
parts for aseptic use
- Select and implement equipment used
in formulation or sterilization
- Learn how to avoid pitfalls in this
area
Filling/Freeze Dry Operations
- Equipment used in filling operations
- Understand what should be qualified
- Simplified qualification approaches
- Learn how to avoid some pitfalls in
filling equipment selection
Interactive Activity: Developing Documents
Using a case study from a clinical contract
laboratory, attendees will develop selected
documentation for requirements gathering
and vendor selection. Attendees will then
compare and contrast the documents they
develop with each other.
|
| 2:30 PM - 2:45 PM |
Mid-Afternoon Refreshment
|
| 2:45 PM - 4:15 PM |
Sterility Testing
Program - Sampling and Incubation
- Purpose of sterility testing and current
industry issues
- Steps for establishing a sterility
sampling program
- Common causes for sterility failures;
equipment, process and personnel
- Compendia requirements for media and
incubation conditions
- Comparing and interpreting sterility
test results with media fill results
- Product disposition issues: how to
assure quality with known manufacturing
deviations
Strategies for Investigating Sterility
Failures
- Using Corrective and Preventative Action
Plan (CAPA)
- Roles and responsibilities and how
to conduct laboratory and manufacturing
OOS investigations
- Importance of trending results
- Common deficiencies associated with
OOS investigations
|
| 4:15 PM – 4:30 PM |
Questions and Answers |
| Day 2 |
Friday, August 15th,
2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast
|
| 8:30 AM – 10:30 AM |
Regulatory Guidelines
and Expectations for Good Aseptic Practices
- Review GMP Guidelines and expectations
for Aseptic Processing
- Review the major components of aseptic
processing
- Reference the FDA 2004 Guidance for
Sterile Drugs produced by Aseptic Processing.
- Review references from EU/PICs/TGA/
cGMP and Annex #1 for Sterile Products
- Review recent 483 citations for aseptic
processing
Overview of Sterilization Principles
- Principles/concepts of Sterilization
- Discuss common methods of sterilization
- Terminal sterilization
- Steam sterilization
- Dry Heat and radiation
- Chemical/EtO
- Common problems in sterile filtration
- Steps for establishing sterilization
cycles
- Alternative methods of aseptic processing
- Isolator usage
- Blow-fill-and seal
- RABS—Restricted Access Barrier
Systems
|
| 10:30 AM - 10:45 AM |
Mid-Morning Refreshment
Break |
| 10:45 PM – 12:00 PM |
Cleanroom Design,
Operations, and Validation for Aseptic Processing
Cleanroom and Processing Fundamentals
- Defining and attaining an aseptic state
- People in an aseptic area
- Aseptic techniques
- Environmental particles, microorganisms,
and pyrogen
behaviors
- General product requirements
Cleanroom Technology Standards
- Applicable regulations and guidelines
- Design criteria and maintenance programs
- Environmental control, cleaning, and
sanitization programs
- General aspects of process analysis
- Filter integrity, decontamination time,
and contamination
curves
- Cleaning and sanitation methodology
and validation
Cleanroom Monitoring
- Operator qualification
- Reasons to monitor cleanrooms
- Microbial monitoring
|
| 12:00 PM - 1:00 PM |
Luncheon |
| 1:00 PM – 2:30 PM |
Auditing of Aseptic
Processes and Facilities
- Review the procedures, training, and
records required for establishing a compliant
auditing program.
- Applying a quality system-based approach
to auditing
- Discuss risk management issues and
benefits
- Review areas of importance when auditing
of Quality Systems (laboratory, manufacturing,
packaging/labeling, etc.)
- Review personnel training and documentation
requirements
- Discuss effective audit techniques
and common pitfalls
- Review regulatory guidelines regarding
vendor and internal auditing
Interactive Workshop Session:
Conducting a Media Fill Failure Investigation
Attendees review the data and propose actions
for the investigation. |
| 2:30 PM – 2:45 PM |
Questions and Answers
(Conclusion of Program) |
Who Should Attend?
This two day workshop program is directed towards
Directors, Managers, Supervisors, Analysts, and
Associates in the Pharmaceutical, Biopharmaceutical,
and allied industries with responsibilities in
the following areas:
- Quality Control
- Quality Assurance
- Sterility Assurance
- Engineering
- Critical Systems and Maintenance
- Manufacturing
- Production
- Process Development
- Microbial Testing
- Contamination Control
- Environmental Monitoring
- Cleaning Validation
- Regulatory Affairs
- Training
Registration Information:
Registration Fee: $875.00 +
GST
Online Registration
Payment Information
Course Location
& Hotel Accommodations
Registration Fee Includes:
Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions
Policy:
CANCELLATION POLICY:
Cancellation is accepted in writing (by mail,
or fax) up to 4 weeks before the program start
date, after which cancellations are not accepted
and do not qualify for refund or credit. All Cancellations
are subject to a $210.00 CAD (incl. GST)/person
processing fee. Substitution of delegate/s with
the member/s of the same organization is permitted
at any time. IPA reserves the right to postpone
an event, prior to which time all the registered
attendees will be notified a minimum of 2 weeks
in advance. IPA shall not be responsible for any
air fare, hotel or transportation costs incurred
by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance
upon completion of the course
For registration or any further
information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
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