It will provide an overview of the FDA inspection process in general along with a background and understanding of the role played by the Agency, its administrative and enforcement powers
It will provide an overview of the FDA inspection process in general along with a background and understanding of the role played by the Agency, its administrative and enforcement powers. The seminar will provide a description of the inspectional process with specific examples regarding cGMP compliance inspections and pre-approval inspections.
The latest FDA initiatives regarding inspections like risk based approach and system based approach, will also be discussed. This will enable participants to better understand how to prepare their companies for FDA inspections.
Areas Covered in the seminar:
- FDA Structure, Function, Authority
- Inspection Rationale and Process
- Preparing for Inspection
- Latest FDA Inspection Initiatives
- Pre-Approval & Regular cGMP Inspections
- FDA inspection Do’s and Don’ts
Who Will Benefit
- Regulatory Affairs
- Quality Assurance/Control
- Plant Management
- Auditing
- Engineering
- Research & Development
- Quality Systems Management
- Documentation Management
- VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
Instructor Profile
Ashish Talati is an Associate at Amin Hallihan, LLC. whose key practice areas include Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S. Customs, U.S. Drug Enforcement Agency (DEA), U.S. Department of Agriculture (USDA) and related Federal and State regulatory compliance and litigation matters, advertising law, intellectual property including patents, trademarks, copyrights, trade secrets and licensing, contracts, and business litigation. Ashish R. Talati primarily counsels companies and trade associations in the pharmaceutical and biotechnology industry on a wide range of issues surrounding U.S. Food and Drug Administration’s (FDA) review, approval, and oversight of drug and biological products. He counsels such drug and biotechnology clients as well as food, dietary supplement, cosmetic and medical device companies on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf before the FDA, FTC, Customs, USDA, DEA and other federal and state agencies, and in court.
Mr. Talati has significant experience managing compliance and crisis situations and frequently speaks at industry conferences and seminars. Mr. Talati has provided training to consultants on various FDA related regulations including 21 CFR Part 11, GxPs, HIPPA, PDMA, DSHEA etc. Mr. Talati has consulted on regulatory issues for over 6 years assisting major pharmaceutical and biotechnology companies in assessing their compliance programs and in reviewing and revising policies and procedures governing compliance with the FDA’s rules and regulations.
