ComplianceOnline

With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.

This seminar will guide all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply the fundamental change control steps and best practices. The key focus will remain on:

  • Change proposals
  • Justification / risk assessment
  • Change execution / implementation

The seminar will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc. Document change control will be discussed as a supporting element. Additionally, this practical, how-to course will illustrate and impart:

  • The importance of subject matter expertise, proper planning, critical thinking skills, and co-ordination of all change activities.
  • Skills needed for applying change controls within an organization.
  • Group exercises to allow participants to practice skill sets with feedback from the instructor.
  • Practical training by having participant teams complete a full write-up for a mock change control.
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

Learning Objectives:

On completing this course on FDA compliance, participants will be able to:

  • Understand regulatory requirements and FDA expectations for change control
  • Understand the purpose of change control
  • Identify what types of changes are /are not subject to change control
  • Properly describe a change
  • Properly justify a change
  • Develop a comprehensive change execution plan
  • Conduct a proper change risk assessment
  • Accurately execute a change
  • Accurately implement a change
  • Develop a full change control package
  • Utilize critical thinking skills throughout the change control process
  • Avoid pitfalls during the change control process

Who Will Benefit:

This course is designed from a pharmaceutical manufacturing perspective; however, since the main focus is on techniques and practices, the course material may be equally applied to biologics and medical device environments. It will benefit:

  • Change proposal authors
  • Reviewers / approvers of change controls
  • Change control system owners
  • Production staff / management
  • Engineering staff / management
  • Validation staff /management
  • QA and QC staff / management
  • Regulatory affairs staff / management

Topic Background:

One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes do not adversely impact products, processes, equipment, facilities, etc. Any individually inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.

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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Regulatory Requirements
  • FDA Change Control Expectations / Warning Letter Examples
  • Purpose of Change Controls
    • What is Change Control?
    • Why Change Control?
    • A Different Way of Thinking
  • Change Control Process Model
    • 5 Part Process Model
    • Key Terms and Definitions
  • Types of Changes Subject to Change Control
    • Products, Materials, Suppliers, Processes, Facilities, Equipment, etc.
    • Like-for-Like Changes
  • Change Proposal
    • Current State / Proposed State
    • Group Exercise - Change Proposal
  • Change Justification
    • Science and Compliance Rationale
    • Group Exercise - Change Justification
  • Change Execution Plan
    • Key Elements
    • Group Exercise - Change Execution Plan
  • Change Proposal Assessment
    • Risk Assessment
    • Validation, Technical, Regulatory, Quality Assessment
    • Group Exercise - Change Risk Assessment
Day 02(8:30 AM - 4:30 PM)
  • Executing the Change
    • Key Elements
  • Implementing the Change
    • Key Elements
  • Change Control Documentation
    • Key Elements
  • Putting It All Together: A System Viewpoint
  • Change Control Workshop
    • Participant Teams to Write-Up Mock Change Control, Based on Case Studies Provided by Trainer
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Andrew Campbell

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management.

Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key quality systems. He is a skilled GMP auditor, and has audited multiple API, drug product, packaging, testing, and distribution facilities. He is an experienced GMP trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems.

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August 3-4, 2017, Irvine, CA

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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.

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Location

Embassy Suites by Hilton – Irvine
Orange County Airport,
2120 Main Street, Irvine,
CA 92614, United States
Tel: +1 949-553-8332

August 3-4, 2017

How to Reach

General Driving Directions:

Driving Directions from John Wayne Airport/Orange County: 2.5 mi
  • Depart Airport Way (0.0 mi.)
  • Keep left onto road (0.6 mi.)
  • Keep left toward Airport Way (0.1 mi.)
  • Keep straight onto Airport Way (0.2 mi.)
  • Turn right onto MacArthur Blvd (0.2 mi.)
  • Turn left to stay on MacArthur Blvd (0.2 mi.)
  • Turn right onto Michelson Dr (0.4 mi.)
  • Turn left onto Von Karman Ave (0.5 mi.)
  • Turn left onto Morse Ave (0.1 mi.)
  • Turn right onto Gillette Ave (0.1 mi.)
  • Arrive at Gillette Ave on the right (0.0 mi.)
Driving Directions from Los Angeles International Airport, CA: 42.5 mi
  • Depart from Los Angeles International Airport, CA (0.0 mi.)
  • Turn left, and then immediately turn right onto W Century Blvd (0.3 mi.)
  • Turn left onto CA-1 S / S Sepulveda Blvd (0.8 mi.)
  • Take ramp right for I-105 East toward Norwalk (1.3 mi.)
  • Take ramp right for I-405 South toward Long Beach (24.5 mi.)
  • Keep left to stay on I-405 S (13.9 mi.)
  • At exit 7, take ramp right and follow signs for Jamboree Rd (0.3 mi.)
  • Turn right onto Jamboree Rd (0.2 mi.)
  • Turn right onto Michelson Dr (0.4 mi.)
  • Turn right onto Von Karman Ave (0.5 mi.)
  • Turn left onto Morse Ave (0.1 mi.)
  • Turn right onto Gillette Ave (0.1 mi.)
  • Arrive at Gillette Ave on the right (0.0 mi.)

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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