IMPLEMENTATION & MANAGEMENT OF A COMPLIANT CHANGE CONTROL PROGRAM
Venue: Hilton Toronto Airport
|Event Date/Time: May 02, 2005||End Date/Time: May 03, 2005|
WORKSHOPS & CASE STUDIES ON:
- Regulations and Requirements
- Change control as critical part of the validation life cycle
- How to set up Change Control, Documentation Systems
- Preparing Change Control SOPS & Forms
- Processes involved to efficiently control and document changes to:
- Manufacturing processes
- Elements of Change Control Management
- Change Control process for computerized systems
- Change Control in Medical Device industries
- How to organize change documentation to withstand regulatory queries during field inspections?
- What functions a Change Control system must perform
- How the organizational culture can affect the successful implementation of Change Control
- Types of Change
- Different levels of change (major, minor, critical) and distinguishing them
- Types of reviews and approvals
- Roles and Responsibilities
- How your Change Control system may be examined by investigators
- Change Control checklists
- Personnel Training
- Scale Up and Post Approval Changes - SUPAC
WORKSHOPS & CASE STUDIES ON:
- Preparing Change Control SOP
- Preparing Change Control Form
- Case Studies
- Review of FDA recent 483s on Change Control
- Examples of Noncompliance
Mr. Tom Feyerabend
Mr. Feyerabend is currently the Director of Quality Systems Consulting with PAREXEL Consulting, formerly KMI/PAREXEL, and has been with PAREXEL for four years. He has more than 25 years of Quality Management experience in food, pharmaceutical, medical device, and biologics industries. This experience includes quality systems development and implementation, quality assurance program development and implementation, strategic planning, testing laboratory management, quality engineering, supplier/contractor and internal regulatory and quality systems auditing.
Mr. Feyerabend has been a presenter of various topics for Pharma Conference, the American Society for Quality (ASQ), and was the keynote speaker for an American Blood Resources Association (ABRA) seminar on validation.
As the Director of Quality systems consulting, Mr. Feyerabend’s services include: the development and implementation of client quality systems/programs; performance of gap analyses and audits wherein the current state of systems and programs are compared with desired state requirements including domestic cGMPs, international regulations, and other regulatory and quality standards; generation and implementation of policies, procedures, and other program documents; project management, and executive-on-loan services. Mr. Feyerabend has performed multiple training sessions for newly developed quality systems in large group settings.
Prior to joining PAREXEL Consulting, Mr. Feyerabend was the Director of Quality Assurance and Regulatory Affairs for the Plasma Division of Alpha Therapeutic. Mr. Feyerabend’s QA/RA responsibilities included all plasma donor centers; the clearing, storage, and distribution facility for all source plasma units; the testing laboratory for all source plasma units; and a medical devices manufacturing facility.
Prior to Alpha Therapeutic, Mr. Feyerabend was the Director of Quality Assurance for the South Central Area of the Biomedical Services Division of the National American Red Cross. While at the American Red Cross, Mr. Feyerabend was influential in the development of national and international quality programs.
Mr. John E. Lincoln
Mr. Lincoln, principal of J. E. Lincoln and Associates, a consulting company with over 20 years experience serving FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the US, Mexico, Canada, France, Germany, China, and Taiwan. He specializes in client culture/systems change in product-to-market, defect and cycle time reduction, software documentation/validation, quality/regulatory management, product clearance, and issue resolution. He’s held assignments as Director of QS/RA, VP R&D, senior QA engineer, and senior manufacturing engineer working for such companies as Abbott Laboratories and Malinckrodt Medical. Additional experience has been in government (civil and military), aerospace, and the electronics industries. He has published numerous peer-reviewed articles on culture change, training, biohazards, quality, and regulatory affairs, as well as a bimonthly newsletter, Medical Device News.
Mr. David M. Stephon
Mr. Stephon is the Vice President of Quality Assurance at Adolor Corporation, Exton, Pa. He has over seventeen years experience in the pharmaceutical industry in both commercial and clinical development operations. Previous areas of his responsibility include management positions in CMC operations, quality assurance and regulatory compliance. Mr. Stephon expertise include development of quality system, protocol design, quality procedure development and international cGMPs for commercial and clinical GMP manufacturing operations.
Mr. Stephon has extensive experience with FDA Pre Approval Inspection programs, EMEA pre-authorization inspections, setting up and maintaining supplier and internal auditing programs, Change Control management, Validation Master Planning (VMP), equipment/utility qualification and clinical and commercial manufacturing operations for API, biologicals, and non-sterile and sterile finished product manufacturing. Extensive background in conducting audits of non-US based suppliers and handling both FDA and EMEA Pre-Approval Inspections.
In addition he is experience in providing training seminars to industry on change control, establishing a material review board, validation requirements and US initiatives for FDA Pre Approval Inspection program. Mr. Stephon has published numerous articles in major trade journal for handling Out-of-Specification (OOS) results, failure investigations, Change Control, supplier qualification programs and development reports. He is also familiar with configuring, validating and managing quality database tracking systems.
Who Should Attend?
This program is specially designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamins, Herbals, and allied industries with daily responsibilities in the following areas:
- Quality Assurance
- Quality Control
- Analytical Laboratories
- Compliance Auditing
- Data Review
- Regulatory Affairs
- Change Control
- Documentation and Technical Writing
- Contract Services