FDA cGMP Audits and Inspections


2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9010)

FDA cGMP Audits and Inspections

KENNETH CHRISTIE

VTS Consultants

May 3 – 4, 2018

Philadelphia, PA, USA

 

Why You Should AttendAgendaSpeakerPricingVenue
What are the Current Good Manufacturing Practice regulations (cGMP) for Finished Pharmaceuticals (cGMP)? Why is it required to follow these regulations? This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules.

You will learn how to prepare for and what is the appropriate conduct during FDA Inspections. Acquire the suitable skills necessary for responding to FDA’s questions. Descriptions of what records you have to provide and what records you should not provide to FDA. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections.

The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data.


Areas Covered in the Session:

  • cGMP for Finished Pharmaceuticals
  • cGMP for APIs
  • Buildings & Facilities, Equipment, Control of Components
  • Documentation and Change Control
  • Quality Protocols
  • Data Integrity
  • Electronic Records and Signatures
  • FDA Inspection Guides
  • Top 10 most common cited FDA Inspectional Observations (cGMP deficiencies)
  • Recent FDA Warning Letters

Who Should Attend:

  • Quality Control Departments
  • Quality Assurance Departments
  • Research and Development Departments
  • Engineering Departments
  • Regulatory Departments
  • Manufacturing Departments
  • Validation Departments
  • Production Departments
  • Documentation Departments
  • Supply Chain and Logistics Departments
 
 

Seminar Fee Includes:
Training
Lunch
AM-PM Tea/Coffee
Seminar Materials
USB with Presentation Handout
Attendance Certificate
Networking Sessions
$100 Gift Voucher for next seminar

DAY 1 (8:30 AM – 4:30 PM):

Registration Process – (8:30 AM – 8:45 AM)

Review of GMP Regulations

  • How the industry dictates changes

Current Good Manufacturing Practices

  • Good Documentation Practices
  • Change Control Procedures
  • Validation Protocols including FAT, SAT, IQ, OQ and PQ
  • Validation of Utilities, Facilities and Equipments

cGMP for API & Finished Products

  • Review current FDA guidance for API manufacturers
  • CReview regulations for sterile products

DAY 2 (8:30 AM – 4:30 PM):

 
 
Data Integrity

  • Current focus by FDA and practices that should be in place
  • Recent FDA Observations
  • Part 11 Compliance

FDA Inspection Guides & Audit

  • Current FDA Audit Approaches
  • Top 10 most common cited drug manufacturing GMP deficiencies

FDA Inspectional Observations and Warning Letter Citations

  • Recent warning letter topics issued by FDA

Each day’s training will include actual case studies to highlight topics covered, review of applicable forms that can be used as templates for change control, or audit checklists, etc. Attendees will have ample opportunity to ask questions regarding current industry practices or their own company practices.

 

Kenneth Christie

President, VTS Consultants
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 Amherst, MA. Specifically, his responsibilities 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. Mr. Christie 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, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

PRICING OPTIONS
For Single Delegate – $ 1100 (Save $ 300 on Early Bird Discount)
Regular Price – $ 1400

Group of 3 Delegates – Get 10% Discount (Save $ 1230)
Group of 5 Delegates – Get 20% Discount (Save $ 2600)

EARLY BIRD OFFERS CLOSES ON APRIL 12, 2018
 
 
 
 
Early bird seats are limited and based on first-come, first-serve..(Only 5 Remaining)
 

For discounts on multiple registrations, contact customer care at +1-416-915-4458

 
REGISTER NOW


Payment Options

Register Online:

  • Make Secure Payment using Credit Card
  • Click on Register Now, and you will be redirected to Payment Options page.
  • Please choose your option (No. of delegates) from the drop down and click on Add to basket
  • Click on Proceed to Checkout on the Cart Page, and complete the registration.
  • Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
  • An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
  • Please bring the respective passes to the event venue.

Pay by Wire:

  • Please contact our support to assist you with registration by Wire
  • Support Number: +1-416-915-4458
  • E-mail: info@webinarcompliance.com

By Check:

  • Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
  • Please send the Scanned copy of the check to info@webinarcompliance.com
  • Mail the check to:
    FutureCorp Consulting Inc
    5969, Candlebrook Ct.,
    Mississauga, ON L5V 2V5,
    Canada
  • Once we receive the check, you will be receiving a Form to fill up the Delegates Information
  • After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.

DoubleTree by Hilton Hotel Philadelphia Airport

Philadelphia, PA, USA | May 3 – 4


 

Call for Assistance: +1-416-915-4458

 

REGISTER NOW