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COMPUTER SYSTEM VALIDATION


 * "The Course Director managed to turn potentially dull subject into an
   interesting course. Good balance between basics and in-depth subjects,
   accompanied by examples and anecdotes from current practice."
   
   
   Bas K., Senior Mfg Engineer, Brunel
   
   


 * SLIDE TITLE
   
   "Course was superb! The Course Director was knowledgeable and his
   presentation was flawless. This was my first course with CfPIE and I will
   certainly look for additional courses relative to my specific expertise."
   
   
   Henri S,. Aventis
   
   


 * SLIDE TITLE
   
   "This is an excellent course for anyone wanting to learn generally accepted
   validation practices."  
   
   
   Sarah L., Document Specialist II, Mallinckrodt
   
   


 * SLIDE TITLE
   
   "One of the better training courses I have taken. The course director did a
   wonderful job and was very enthusiastic. The real life examples provided were
   helpful to tie the concepts together and demonstrate how they apply."
   
   
   Jenna N., Senior Associate, PwC
   
   

 * "The Course Director managed to turn potentially dull subject into an
   interesting course. Good balance between basics and in-depth subjects,
   accompanied by examples and anecdotes from current practice."
   
   
   Bas K., Senior Mfg Engineer, Brunel
   
   


 * SLIDE TITLE
   
   "Course was superb! The Course Director was knowledgeable and his
   presentation was flawless. This was my first course with CfPIE and I will
   certainly look for additional courses relative to my specific expertise."
   
   
   Henri S,. Aventis
   
   

Next Course


DATE & LOCATION


APR 11 - APR 13, 2022.

VIRTUAL (12:00 TO 17:00 - UK TIME)


Register

COURSE DIRECTOR

G. RAYMOND MILLER, PH.D.

COURSE FEE


$2150.00 REGULAR REGISTRATION


$1950.00 EARLY BIRD PRICING (REGISTER 30 DAYS IN ADVANCE)


COURSE BROCHURE


CLICK TO DOWNLOAD COURSE BROCHURE


NEXT AVAILABLE DATES

JUL 28 - JUL 29, 2022. VIRTUAL (9:00 TO 5:00 CDT)

NOV 3 - NOV 4, 2022. VIRTUAL (9:00 TO 5:00 CDT)

ACCREDITATION: RAPS APPROVED COURSE


PHARMATRAIN RECOGNIZED COURSE



COURSE DESCRIPTION

This computer system validation course focuses on developing and implementing
regulated computer systems with an appropriate level of documented evidence to
satisfy FDA expectations. The course targets deliverable document content and
how to avoid rework and unnecessary expense through a proactive approach. The
core elements of a satisfactory computer validation program will be emphasized.

Topics to be discussed include:



 * The regulatory expectations for computer validation
 * Relevant FDA warning letters
 * The tasks and deliverables expected for computer validation
 * Why validation processes vary so much
 * Strategies for practical, yet defensible computer validation
 * Sops required for system operation and maintenance
 * 21 CFR part 11 and it's implications for common regulations
 * An active discussion of part 11 examples and audience questions
 * The implications of GAMP 5 on computer validation and how to transition from
   GAMP 4
 * Auditing GXP computer systems and suppliers


WHY THIS COURSE MATTERS

The Chemistry, Manufacturing & Controls (CMC) landscape of biologics is
undergoing rapid development and constant change. In addition to commercial
recombinant proteins and monoclonal antibodies, there are now biosimilars,
antibody drug conjugates (ADCs), cellular therapy and gene therapy medicines.
Vaccine manufacturing employing genetic engineering approaches has resurged due
to the concerns of potentially pandemic mutated animal influenzas (e.g.,
COVID19). Strategic international regulatory guidances have been adopted that
are driving the entire pharmaceutical industry, including biologics, to a higher
standard of performance, including Quality by Design (QbD), Quality Risk
Management (QRM) and Pharmaceutical Quality System (PQS).



Therefore, it is most important for a biologic company to have an effective CMC
regulatory compliance strategy that can meet both FDA and EMA requirements and
expectations. At each stage of drug development, from early stage clinical
development through commercialization, the basic question needs to be addressed:
‘What is absolutely necessary from a CMC regulatory compliance perspective to be
successful in moving our biopharmaceutical/biologic through clinical trials and
into the market, but without impacting patient safety or creating delays in the
program?' Deficiencies in the CMC regulatory compliance strategy have resulted
in recent devastating clinical holds and market approval delays.


WHO SHOULD ATTEND

This FDA computer system validation course is designed for Validation, Quality,
IT, and Business personnel responsible for implementing and using regulated
computer systems in the pharmaceutical, biotech and medical device industries.
The course is of special value to personnel seeking experience with computer
validation and issues associated with FDA regulated computer systems. The
computer system validation course is especially designed for attendees seeking a
thorough introductory level of understanding, yet is also designed to be
valuable to those with prior experience seeking to remain current with industry
trends and approaches.

Register


 * LEARNING OBJECTIVES
   
   
   
   The course is designed to provide a thorough understanding of computer system
   validation. In addition, the course will address how 21 CFR Part 11
   (electronic record/electronic signature requirements) fits into the
   validation process. The attendee will be familiar with expected content for
   computer validation deliverables through examination of example documents, as
   well as how to develop the validation rationale for a variety of
   circumstances.


 * AGENDA
   
   
   
   First Day
   
   
   Computer Validation – General Overview
   
    * Computer Validation fundamentals – a walk-through of a complete validation
      of a small example system
    * Who needs to validate?
    * What is Computer Validation?
   
    1. Core principles
    2. Brief history of computer validation
   
    * Why is validation necessary and what regulations guide validation
      requirements?
    * Review of the computer validation references in regulations and guidances:
   
    1. 21 CFR Part 211
    2. 21 CFR Part 810
    3. 21 CFR Part 11
    4. Annex 11: Computerized Systems
    5. Guidance: Q7A GMPs for Active Pharmaceutical Ingredients
    6. Guidance: General Principles of Software Validation
    7. Guidance: Computerized Systems Used in Clinical Investigations
   
    * When and how are systems validated?
    * Review of key FDA Warning Letters related to computer validation
   
   Computer Validation Process and Deliverables
   
    * What is the SDLC (System Development Life Cycle) process?
    * How does computer validation fit into the SDLC?
    * What content must be covered?
    * What are the expected tasks and deliverables?
    * System/software specifications
    * Requirements options and documentation
    * How 21 CFR Part 11 applies to computer validation
    * Design Qualification (DQ) and vendor selection
    * Risk Assessment in computer validation
   
    1. Where does it apply?
    2. A walkthrough of the GAMP risk assessment process
   
    * Validation Plans and Master Validation Plans
    * Installation Qualification (IQ)
   
    1. ­The five topics expected in IQ documents
   
    * Operational Qualification (OQ) and Performance Qualification (PQ)
   
    1. ­Testing strategies and level of detail
    2. How much testing is enough?
    3. Examples of effective test cases and system errors discovered
   
    * SOPs required for system operation and maintenance
   
    1. ­How they related to FDA Warning Letters
   
    * Validation Summary Reportse
   
   Day 1 wrap-up
   
    * General questions and answers
   
   Second Day
   
   
   Overview of 21 CFR Part 11 (Part 11)
   
    * Background and purpose of Part 11
    * Overview of Part 11 (review regulation)
    * Review of the Part 11 implications in regulations and guidances:
   
    1. 21 CFR Part 58 GLP
    2. ­21 CFR Part 211 GMP
    3. ­21 CFR Part 312 GCP (IND)
    4. 21 CFR Part 810 QSR
    5. Guidance: Part 11 scope and application (September 2003)
    6. Guidance: Computerized Systems Used in Clinical Investigations
    7. Guide to the Inspection of Pharmaceutical Laboratories
   
    * Review of Part 11-related FDA Warning Letters
    * Discussion of example systems and the evaluation of Part 11 Compliance
      decisions
    * Industry trends and approaches – the future of Part 11 issues
    * Interactive discussion of Part 11 issues and concerns (bring your
      questions)
    * Achieving and Maintaining Part 11 Compliance
   
   GAMP-Specific Computer Validation Topics
   
    * The industry guidance for Good Automated Manufacturing Practice (GAMP)
    * How GAMP addresses the FDA's expectations for computer validation
    * GAMP 5 versus GAMP 4
    * How to transition to GAMP 5 from GAMP 4
    * A review of the supplementary GAMP guidances and where they apply
   
   Auditing Computer Systems
   
    * Auditing GxP computer systems
    * Auditing suppliers of computer systems for GxP use
    * Auditing developers for customized systems
    * The general process for auditing computer systems
    * Variations that can save time and money
    * Review of an example audit checklist
    * Primary areas of focus (what to look for)
    * Examples of audit findings
   
   Day 2 wrap-up
   
    * Interactive Discussion / Question and Answer Period
    * Additional CSV topics (TBD during course by attendees, "Parking Lot")
    * General questions and answer


 * TESTIMONIALS
   
   
   
   "This was my first training from an outside vendor and it was a great session
   with the Course Director sharing lots of information. I most enjoyed the
   real-life examples which I could compare to my work environment."
   
   Ritu P., Validation Engineer, CAI
   
   
   "One of the better training courses I have taken. The course director did a
   wonderful job and was very enthusiastic. The real life examples provided were
   helpful to tie the concepts together and demonstrate how they apply."
   
   Jenna N., Senior Associate, PwC
   
   
   "This is an excellent course for anyone wanting to learn generally accepted
   validation practices."
   
   Sarah L., Document Specialist II, Mallinckrodt
   
   
   "The instructor was very prepared and provided good material. I especially
   enjoyed the background information on audits and requirements."
   
   Joseph, B., Manager, PwC
   
   
   "The Validation of Computer Systems course was very informative and engaging.
   The instructor was knowledgeable and well spoken."
   
   Laura S., Nordion
   
   
   "Ray was an excellent course director. He made learning about computer
   systems validation a lot of fun. I loved the open discussion involved during
   the course."
   
   Tushar G., Production Operator, IBM
   
   
   "The Course Director managed to turn potentially dull subject into an
   interesting course. Good balance between basics and in-depth subjects,
   accompanied by examples and anecdotes from current practice."
   
   Bas K., Senior Mfg Engineer, Brunel
   
   
   "The Course Director was very knowledgeable and experienced. I would
   certainly recommend this course for anyone who might be interested in
   computer validation."
   
   Robert R., Clinical Data Management, BSD Medical
   
   
   "This course helped me understand the details of computer system
   validation…the ‘what, how and why.' It gave me a framework from which to
   start the validation process."
   
   Deena G., Sr. Manager – Data Management Group, Sunesis Pharmaceuticals
   
   
   "Overall an excellent course. It's a significant accomplishment to deliver
   material of this nature in practical everyday terms."
   
   Maria L., Consultant, SAS Institute
   
   
   "I had no background in CSV and I had no idea how to start the documentation
   of our software validation process according to the FDA compliance. Now I can
   start when I get back to Germany! Thank you to the Course Director. He spoke
   slowly and clearly to help me understand him. I am German and my English is
   not fluent, so this was very important."
   
   Brigitte R., Director HR/Project Manager, DoccuWare AG, Germany
   
   
   "The course covered all the major parts of computer systems validation as
   well as the "why" of doing them. The Course Director could present to
   experienced and neophytes and make it interesting to all."
   
   Sandra D., LIMS Manager, Centocor R&D
   
   
   "Validation is new to me and this course gave me an overall view of what it
   entails. I would recommend this course to others in my company who are in the
   IT department or others who are directly involved with computer systems."
   
   Linda M., Assoc. Product Safety Manager, Eisai
   
   
   "Wish I had taken this course before I validated a system. The instructor was
   very knowledgeable."
   
   Daniel R., Senior Validation Specialist, Glaxo (GSK)
   
   
   "The Course was informative and provided a good foundation for Computer
   Validation. I'd recommend it to anyone new to Computer Validation."
   
   Joe Y., Validation Consultant
   
   
   "Course was superb! The Course Director was knowledgeable and his
   presentation was flawless. This was my first course with CfPIE and I will
   certainly look for additional courses relative to my specific expertise."
   
   Henri S,. Aventis
   
   
   "Good Course. Well Presented!"
   
   Stewart S,. Optos
   
   
   "Lot of information to cover but it was clearly articulated and very useful.
   Specific examples provided to illustrate the ideas were extremely helpful in
   ease of understanding."
   
   Michael H,. Manager IT, Introgen Therapeutics
   
   
   "The vendor questionnaire for FDA Software application alone paid for the
   course. Well done!"
   
   Romeo P,. Johns Hopkins University


FAQS

 * Does the course go beyond combination product information for the US market?
   
   
   No. The course covers FDA's regulations which govern the US market only.

 * What materials come with the course?
   
   
   A course notebook is provided that contains the slides that are presented,
   publicly available reference materials from FDA and other entities, class
   exercises, and example documents.

 * Are there particular types of combination products emphasized?
   
   
   The course necessarily covers a broad range of combination products. There is
   greater emphasis on the process related to Combination Products as compared
   to deeper evaluations of the specific technologies for any given product.

 * Does the course provide guidance on how to write combination product
   applications (in order to get to market)?
   
   
   The course does not provide in-depth evaluation of important aspects such as
   style, format, level of detail, and other aspects that can only come from
   experience gained in the medical device, drug, or biologics industry(ies) or
   potentially looking at other application examples. Emphasis is placed on how
   the product will be regulated and what product applications would be
   required. Further, emphasis is placed on regulations outside of product
   applications. One key example is how to manage a Combination Product in terms
   of quality systems. Considerable emphasis is FDA's available resources.


CERTIFICATION TRACKS

 * (CPVP) Certified Process Validation Professional™
 * (GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™
 * (CMDCP) Certified Medical Device Compliance Professional™


RELATED COURSES

 * Effective Document Management for Pharma, Biotech & Medical Device
 * Process Validation for Drugs and Biologics
 * Medical Device Process Validation Training for Professionals

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile
Account during the registration process. Creating an Account helps you view your
order history and manage your training programs. If you are registering for
others, please set up an Account in the Attendee’s name. If you are registering
more than one person, you’ll need to set up a separate account for each
Attendee.



Since 2006 CfPIE has

32920
People Trained
736
People Certified
5549
Companies, government agencies and nonprofit organizations served.

We'll find the right course for you.

Analytical Method Validation for Biologics, Biopharmaceuticals and Other
Therapeutic Products™




Complex processes yielding complex products such as biologics and
biopharmaceuticals demand numerous, non-compendial, and sometimes complex QC
test methods to confirm manufacturing consistency and product quality.  This
course provides a comprehensive overview of the international regulatory
authority requirements and expectations for test method validation of these
assays.  This course will prepare attendees with the knowledge and tools to plan
and execute test method validation packages for the NDA, BLA and MAA market
application dossiers, covering in-process, release and stability assays commonly
used by QC in biologic and biopharmaceutical companies.  The course will cover
validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide
mapping, etc.), cell-based potency bioassays, immunochemical binding impurity
assays and adventitious agent assays.




Implementing an FDA Compliant Stability Program




Quality assurance studies for active pharmaceutical ingredients (APIs) and
pharmaceutical drug products, both chemical drugs and biologics, are essential
for product quality and patient protection. The goals of the stability program
are (1) to determine an appropriate and safe stability profile during clinical
development and (2) to justify a shelf-life for the product to enter the market
for FDA regulatory compliance.




The approach to stability testing and interpretation of stability data has
undergone significant change. Strategic international ICH regulatory guidance’s
have been adopted that are driving the entire pharmaceutical industry, including
both chemical drugs and biologics, to a higher standard of performance,
including Quality by Design (QbD), Quality Risk Management (QRM) and
Pharmaceutical Quality System (PQS).




Need help finding the right life sciences training courses? We can help you make
the right choice based on your company's needs.

Chat with us

Or

Give us a call

ABOUT US

THE CENTER FOR PROFESSIONAL INNOVATION AND EDUCATION (CFPIE) PROVIDES TECHNICAL
TRAINING FOR PHARMACEUTICAL, BIOTECH, MEDICAL DEVICE AND SKIN/COSMETICS
PROFESSIONALS. CFPIE OFFERS MORE THAN 350 CLASS SESSIONS ANNUALLY ACROSS 80
COURSE TITLES IN MULTIPLE FORMATS, SUCH AS CLASSROOM, ON-SITE, AND CERTIFICATION
PROGRAMS.

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CfPIE, Inc. and may not be used or reproduced without the written permission of
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