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Event :The Challenges of an Effective Change Control Program 2017

Dates :Thursday August 17th, 2017 - Friday August 18th, 2017

Location :DoubleTree by Hilton Hotel San Diego Downtown
1646 Front Street
92101 San Diego, United States

Type :Education - International audience

Accreditation :--


 

Further information

Course "The Challenges of an Effective Change Control Program and How to Address OOS Results" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

Overview:

 

An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and also a form by which required information is recorded. The effectiveness of these items will determine the success of your change control program and help assure regulatory auditors that your equipment, utilities and systems remain in a state of control.

 

This seminar will concentrate on three major points:

 

  • The regulatory requirements for change control and what it applies to.
  • How to develop a change control SOP that will define what is required, responsibilities, and a means to quickly provide summaries of changes to investigators.
  • What are some of the common deficiencies cited by regulatory auditors?

In addition, the webinar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required. Attendees will be able to ask questions on issues relating to their own change control procedure.

As sure as we know things will change over time, the same we know that not all results from laboratories, equipment qualifications and product testing will meet defined acceptance criteria. Once this happens, companies must first determine cause, take the required corrective actions and then implement actions to prevent their re-occurrence. The effectiveness of these actions is being able to determine the root-cause otherwise actions taken will not prevent them from happening again. This second part of the seminar will focus on the FDA Guidance document as to how to conduct such investigations and what is expected. Actual case studies will be used to highlight the various topics covered.

 

Why you should attend:

 

It is said that the two things no one can avoid in life are death and taxes, but in industry, these items are change control and out of specification results that will eventually happen. How we document them and their evaluation are critical to an effective quality system program. In review of the top 10 most cited GMP deficiencies, these two topics have routinely made the top 10 list for the last five years and understanding how best to address them will help companies avoid getting cited for the same issues.

 

Areas Covered in the Session:

 

  • Review the current regulatory requirements for change control.
  • Discuss when change control needs to be implemented and the main items it should cover.
  • What are the major sections that need to be included in a change control procedure?
  • What are the typical industry challenges associated with change control procedures?
  • Review the benefits that a well-controlled change control process can provide.
  • What are the most common deficiencies cited by regulatory auditors when auditing change control programs?
  • Review the current regulatory requirements for change control.
  • Discuss when change control needs to be implemented and the main items it should cover.
  • What are the major sections that need to be included in a change control procedure?
  • What are the typical industry challenges associated with change control procedures?
  • Review the current FDA Guidance for the investigation of Out of specification results (OOS)
  • Review typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc.

 

Who Will Benefit:

 

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Production
  • Regulatory
  • Laboratory Personnel
  • Management
  • Equipment Vendors

 

Agenda:

 

 

Day 1 Schedule

 

Lecture 1:

Review the current regulatory requirements for change control. Discuss when change control needs to be implemented and the main items it should cover.

Lecture 2:

What are the major sections that need to be included in a change control procedure?

Lecture 3:

What are the typical industry challenges associated with change control? Review the benefits that a well-controlled change control process can provide.

Lecture 4:

What are the most common deficiencies cited by auditors when reviewing change control programs? Review the current regulatory requirements for change control.

 

Day 2 Schedule

 

Lecture 1:

Discuss when change control needs to be implemented and the main items it should cover.

Lecture 2:

What are the major sections that need to be included in a change control procedure?

Lecture 3:

Review the current FDA Guidance for the investigation of Out of specification results (OOS)

Lecture 4:

Review typical evaluation methods used for determining probable cause such as fault tree, fish diagrams, etc. Discuss actual case studies to highlight topics covered. Question and answer period from the attendees.

 

 

Speaker

Kenneth Christie


 

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc., located in Amhesrt, MA. His responsibilities specifically include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. He also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the validation manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, he serves as a member of the ISPE's Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.

               

Location:  San Diego, CA Date:  August 17th & 18th, 2017 and Time: 9:00 AM to 6:00 PM      

 

Venue:  DoubleTree by Hilton San Diego Downtown   1646 Front St, San Diego, CA 92101, USA

 

Price:

 

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 10, Early Bird Price: $1,295.00 From july 11 to August 15, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

 

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901094SEMINAR?doctorama-August-2017-SEO

 

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Location

Education address :
DoubleTree by Hilton Hotel San Diego Downtown
1646 Front Street
92101 San Diego
United States

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GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and [...]

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The Challenges of an Effective Change Control Program 2017 Medicine - Pharmacy
change control process, change management system, change control management, change management process document, change management, regulatory compliance training, regulatory compliance services, environmental regulatory compliance
Professionals, Quality Assurance Quality Control Manufacturing Production Regulatory Laboratory Personnel Management Equipment Vendors
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English

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