May 3 – 4, 2018
Philadelphia, PA, USA
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
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):
- 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.
President, VTS Consultants
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.
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- Please bring the respective passes to the event venue.
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FutureCorp Consulting Inc
5969, Candlebrook Ct.,
Mississauga, ON L5V 2V5,
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- 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