Technical Writing
and Document Management
Strategy for preparation of comprehensive SOPs,
Protocols and Reports
A ONE & HALF DAY COMPREHENSIVE & INTERACTIVE
COURSE ON:
- GMP, GLP Requirements and Regulatory Expectations for SOPs
- The SOP’s Role within a Quality Management System
- Auditing of SOP Compliance
- Performing a GAP Analysis of SOP Systems
- Minimizing SOP Review and Approval times
- Electronic vs Paper-Baed Document Mangement Systems
- Electronic Approval and Electronic Access
- Change Control of your SOPs
- Managing the Preparation of SOPs
- SOP Formats vs. other Document Formats
- Integrating SOPs with other Documents
- Writing Techniques for Effective Instruction
- Controlling Sequence of Actions
- Determine target audience, how SOPs will be used
- Assessing SOP Quality and Effectiveness
With Interactive Exercises on::
- Determining SOP Requirements
- Classifying Documents and SOPs
- Critiquing SOP Quality
Distinguished Course Leader
 Mr.
Timothy J. Fields President
Drumbeat Dimensions, Inc.
Tim Fields, President of Drumbeat
Dimensions, Inc. (DBD), has over
25 years of experience in the pharmaceutical
industry including 13 years with Pfizer where
he was responsible for organizing and managing
the corporate software quality assurance audit
program, developing GMP training programs for
management level personnel, and conducting numerous
internal and external quality audits.
Mr. Fields has experience in a variety of compliance
areas including sterilization validation, aseptic
processing, computerized system validation,
process validation, cleaning validation, GMP
training, 21CFR Part 11, document management,
calibration, and auditing.
Mr. Fields is a member of the International
Society of Pharmaceutical Engineers (ISPE),
Parenteral Drug Association (PDA), and GAMP
Americas. He has published and lectured worldwide
on various compliance-related topics including
computer-related system validation, electronic
signatures and records, document management,
validation, and GMPs.
Mr. Fields is a member of the Editorial Review
Board for the Journal of GXP Compliance. He
is an adjunct instructor at the Community College
of Rhode Island, where he teaches “Introduction
to Pharmaceutical Compliance”.
Mr. Fields has a B.A. in Biology from Indiana
University and an M.A. in Life Sciences from
Indiana State University.
Program Agenda
| Day 1 |
Tues, September 23rd,
2008 |
| 8:00 AM - 8:30 AM |
Registration and
Continental Breakfast |
| 8:30 AM - 10:15 AM |
- GMP and GLP Requirements for SOPs
- Review worldwide regulatory requirements
for SOPs
- Review FDA Warning letters associated
with SOPs
- SOP Approval requirements
- Regulatory Expectations of SOPs
- SOPs within a Quality Management
System
- Determining what SOPs are required
(Interactive Exercise)
by US GMPs
- FDA System Based Inspection Program
- Expected SOPs
- Definition & Objectives of SOPs
- Understand what an SOP is
- Instructions, Events, Records
- Difference between an SOP and a
Policy
- SOP as a Management Tool
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
- GAP Analysis for SOP Systems
- Taking inventory of SOPs; answering
the question: “What SOPs do you have?”
- Determining what SOPs are missing;
answering the question: “What SOPs
are we missing and where are they
missing?
- Filling the gaps
- The relationship of SOPs with other
documents
- SOPs and associated forms
- SOPs and Manufacturing Instructions
- SOPs and Test Methods
- SOPs and other types of instruction
documents
- SOPs and protocols
- Identifying and minimizing redundancies
- Classifying documents and SOPs
(Interactive Exercise)
|
| 12:00 PM - 1:15 PM |
Luncheon |
1:15 PM - 2:45 PM
|
- General Format and Components of SOPs
- Understanding the importance of a
standard SOP Format
- Exploring standard SOP Formats
- Understanding the importance of each
format component
- SOP Formats vs. other document formats
- Assigning responsibility of preparation
and management of SOPs
- Authoring SOPs
- Identifying Responsibility for
Tasks
|
2:45 PM - 3:00 PM |
Mid-Afternoon Refreshment |
| 3:00 PM - 4:15 PM |
- Preparation of SOPs
- Active vs. Passive Voice in Writing
SOPs
- Determine target audience, how SOPs
will be used
- Controlling Sequence of Actions
- Importance of spelling and grammar
- Writing clearly
|
| 4:15 PM - 4:30 PM |
Questions & Answers |
| 4:30 PM |
Conclusion of Day
One |
|
|
| Day 2 |
Wed, September 24th,
2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast |
| 8:30 AM - 10:15 AM |
- Assessing SOP Quality and Effectiveness
- Answering the question: “How Good
Are My SOPs”
- Importance of quality in an SOP
- Eliminating ambiguity in SOPs
- Defining SOP Quality attributes
- Critiquing SOP quality (Interactive
Exercise)
- Peer & Formal Review
- SOP Review Cycles
- SOP Approval Process
- Minimizing SOP review/approval
times
- Understanding approval requirements
- Defining the purpose of the approvals
- Periodic Review
- Understanding the reason for periodic
reviews
- Defining the review period
- Assigning responsibility for periodic
review
- Addressing the results of periodic
reviews
- Documenting the review
- SOP Change Control
- Exploring how to document the need
for an SOP Change
- SOP changes as a result of other
changes
- Assessing the impact of an SOP
change
- Training in SOPs
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM -12:00 PM |
- Document Control
- Answering the question: “Are the
SOPs available where they are needed?”
- Exploring electronic document management
systems
- Exploring paper-based document
management systems
- Assigning effective dates
- Retention of obsolete SOPs
- Auditing of SOP Compliance
- Determining which SOPs to include
in the audit
- Determining compliance to SOP
- Determining if the SOP needs to
be revised
- Assessing need for retraining in
the SOP
- Documenting the results
- Follow-up
|
| 12:00 PM - 1:00 PM |
Luncheon |
| 1:00 PM - 2:45 PM |
- SOPs and Validation
- Ensuring that SOPs are consistent
with validated process
- Preparing SOPs for validation
- Equipment qualification and operating
SOPs
- 21 CFR Part 11 Issues
- Electronic approvals
- Electronic access
- Audit trails
- Validation
- SOPs for system use
|
| 2:45 PM 3:00 |
Questions and Answers |
| 3:00 PM |
Conclusion of Program |
|
|
Who should attend?
This 2-day conference,
with discussions, case studies and workshops is
directed toward Directors, Managers, Supervisors,
Analysts, and Associates in the Pharmaceutical,
Biopharmaceutical, Devices, and allied industries
with daily responsibilities in the following areas:
- Dissolution
- Quality Control
- Stability
- Analytical Method Development and Validation
- Formulation
- Product Development
- Chemistry, Manufacturing and Controls (CMC)
- Quality Assurance
- GMP/GLP Compliance
- Pre-Clinical Research
- Regulatory Affairs
- Pharmacokinetics/Pharmacodynamics
- Validation
- Calibration/Metrology
- Product Submission
- Training
- Documentation and Technical Writing
- Contract Laboratories
- Consultants
- Contract manufacturing
- and other Compliance professionals
Registration Information:
Registration Fee: $625.00 +
GST
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
|
