Events for October 17, 2013

Event Description

Thursday, October 17, 2013, 8:30 AM to 4:30 PM EDT and Friday, October 18, 2013, 8:30 AM to 1:00 PM EDT, Boston, MA

Course Description:

FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.

This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. In addition, this course will include a list of relevant regulations and guidelines and demonstrate how quality control and quality assurance personnel can monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).

Learning Objectives:

Key goals of the conference will include learning:

• The basics of FDA law and regulations governing QC laboratories responsible for testing research materials, components of FDA-regulated products, and finished FDA-regulated products (pharmaceuticals, biologics, medical devices, cosmetics, and foods).
• Laboratory organization, personnel qualification and training requirements.
• Documentation and record-keeping requirements, including e-records and data integrity.
• Sample integrity requirements.
• Management and control of stability (shelf-life) studies.
• Analytical methods verification and validation.
• Management and control of laboratory instruments.
• Management and control of laboratory supplies.
• Proper conduct of laboratory investigations.
• Consequences of laboratory non-compliance.

Who will Benefit:

Senior directors, managers, supervisors and those who have responsibility for ensuring that QC laboratory operations and practices comply with current good manufacturing practices and good laboratory practices.

• Quality Assurance
• Quality Control
• Research & Development

Meet Your Instructor:



Martha Bennett
Principal, Bennett and Company (Ex-FDA Professional)
Martha M. Bennett, RAC, has more than 40 years of experience in the area of U.S. FDA law and regulations as an investigator, compliance officer, policy advisor to three commissioners, and consultant to companies worldwide regulated by the agency. Ms. Bennett provides a variety of regulatory affairs and quality system (GxP) consulting services to FDA regulated companies worldwide, covering foods, drugs and biologics, medical devices, and cosmetics. Based on almost forty years of experience within and outside of FDA, she assists companies with compliance, product development and approval, and post-marketing issues. Using risk management tools, (e.g., Six Sigma, FMEA, HACCP), she assists companies with validation strategy, planning and execution. She conducts FDA and quality focused audits and training. Thoroughly grounded and experienced in FDA law and regulations, she also provides consulting services to legal teams as well as expert testimony. She was an FDA field investigator, senior compliance officer, and policy analyst for three FDA Commissioners. She is a board member for ASQ-FDC (American Society for Quality – Food, Drug & Cosmetic Division) and SQA (Society of Quality Assurance – Education Committee). Based on her experience and contribution to the profession, she was named a RAPS Senior Fellow.

Further details and registration >>

Event Description

October 17, Thursday 10:00 AM PDT | 01:00 PM EDT

This webinar will provide an update on the U.S. FDA's new Food Safety Modernization Act, its inspectional process and discuss how to prepare for an FDA inspection.

Why Should You Attend:

The FDA Food Safety Modernization Act (FSMA) requires FDA to change the way it regulates the food industry. Previously, FDA's primary mission was to respond to incidents, with minor emphasis on inspections. FSMA now requires FDA to focus its resources on preventing incidents before they happen by requiring the agency to inspect domestic and foreign food facilities, and requires the agency to impose significant fees on inspected companies and their agents if re-inspection is required.

This interactive 60-minute webinar will explain FDA's inspectional process and how to prepare for an FDA inspection. The presenter, a veteran in managing food safety audits and of FDA inspection techniques, will answer your questions at the end of the session.

Areas Covered in the Webinar:

The seminar will cover in detail the following topics:

• FDA Inspection Notice Process
• Facility Registration Requirements
• Facility Personnel Requirements
• Inspection of Grounds and Sanitary Operations
• Equipment and Utensils
• Production and Process Controls
• Review of Records
• Emergency Permit Controls
• Notices of Action
• Avoiding Detentions
• Removal from DWPE

Who will benefit:

• Manufacturers of food
• Processors
• Packaging
• Warehousing and distribution
• U.S. importers sourcing food and beverages from overseas

Instructor Profile:



Mr. Edwin Velez Rivera, is the Director of the Food Safety at Registrar Corp. He is a highly experienced food safety professional, skilled in designing and communicating effective food safety control programs to meet customer, regulatory, and operational needs. Prior to joining Registrar Corp, Mr. VelezRivera worked for 20 years for the U.S. Department of Defense where he managed a wide-ranging food safety and food defense program, including conducting food safety audits, reviewing food defense plans, and managing the audit program for over 600 commercial food establishments.

Mr. Velez Rivera has a master's degree in Food Science and Technology from Kansas State University. He has attended numerous training with the FDA, including "Good Manufacturing Practices (GMP)," "Conducting Seafood Inspections," "Food Code," “Milk Pasteurization Principles and Controls,” and "Inspection Techniques and Evidence Development." He has also completed certification or course work in the following: Advanced HACCP Plan development; HACCP validation and verification; Seafood HACCP; Better Process Control School (LACF and AF); Lead Auditor Training; Advance Auditing Techniques; British Retail Consortium (BRC) Third Party Auditor; Safe Quality Foods (SQF); GMA-SAFE; Certified Quality Auditor (ASQ-CQA); Food Defense Coordinator; US Army Anti-Terrorism Officer Course (Level 2), Agriculture and Food Vulnerability Assessment Course; Food Defense Course for Professionals; and, Certified HACCP Manager.

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