Preparing & Hosting FDA Inspections Before, During and After

Venue: Hilton Toronto Airport

Location: Mississauga, Ontario, Canada

Event Date/Time: Apr 11, 2005 End Date/Time: Apr 12, 2005
Report as Spam



- Mechanics and extent of an FDA inspection
- Types of FDA inspections
- Preparing for FDA Inspections; before, during and after
- FDA’s New initiatives and their impact on inspections
- The FDA Mission and Methods
- Do’s and Don’ts during FDA inspections
- Systems-Based Inspections for Drugs and
- Quality System Inspection Technique (QSIT) for Devices
- Risk management
- Changes to FDA’s ONDC review process
- Process and Analytical Technology (PAT)
- Electronic records/electronic signatures (21CFR11)
- How to handle an inspector
- FDA application integrity policy and import alert system
- How to avoid objectionable findings, 483s,
warning letters, Consent Decree and other regulatory sanctions


- Surviving an FDA Audit: Thinking like an FDA Officer
- How to handle an inspector
- Explore how to respond to FDA 483 comments
- Documents to Have Instantly Available (in-class role playing Lab Inspection exercise)
- How to Prepare for GMP / FDA Inspections - Requirement checklists
- Warning Letters and 483 Case Studies and Preparing Response Letters (Interactive)

Mr. Michael H. Anisfeld
Mr. Anisfeld specializes in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies, national regulatory agencies (including the US-FDA) and over 250 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in North America, Europe and Asia.

Mr. Anisfeld has established and directed quality control, quality assurance, production and materials management functions in the industry as well as directing product development activities. He has instituted innovative, cost-effective auditing programs for his clients, ensuring that they pass regulatory inspections first time through.

Performing over 25 full scale mock inspections annually (to United States FDA, British MCA, Canadian TPP, Australian TGA, and ISO 9000 standards), including audits whose reports are evaluated directly by national regulatory agencies as part of product approval, Mr. Anisfeld has served on both sides of the fence: Inspector and Inspectee! An active member of many European and American regulatory and technical associations, he has served on the Board of Directors of the Parenteral Drug Association, and been Chairman of its Quality Control and Aseptic Processing Task Groups.

An acclaimed international lecturer on the subject of GMP and Quality topics, Mr. Anisfeld is also a prolific author on these topics. He is the editor/author of many books on the subject including: International Drug GMPs, International Device GMPs, Keyword Guide to 21CFR, Guide to FDA International Inspections, Sterile Pharmaceutical Manufacturing, and PDA's monograph Validation of Aseptic Processing of Liquid Drug Products.

Mr. John R. Markus

Mr. Markus is Senior Regulatory/Pharmaceutical Consultant with AAC Consulting Group Inc. in Rockville, MD. Mr. Markus retired from the FDA in 1992. He has over 41 years of experience in the drug regulatory area with 30 years in FDA and 11 years as a GMP/regulatory consultant. While at FDA, Mr. Markus served as an Analytical Chemist in the Cincinnati field laboratory, a Headquarters coordinator of field laboratory and scientist activities, as an acting Chief Chemist of the Seattle District Laboratory, Chief Chemist in charge of the review and approval for the CMC (Chemistry, Manufacturing and Controls) sections of animal drug applications and drug master files. He also served as a member of the generic animal and QC staff. Following retirement, he worked as a Vice President for Regulatory Affairs in industry and then as a private consultant prior to joining AAC in November of 1997. Mr. Markus was a member of the USP Revision Committee from 1980 to 1990.

Mr. John R. Markus
Mr. Markus conducts GMP audits of domestic and international drug manufacturing – APIs and all types of dosage forms including biotech products - and laboratory facilities. He is very knowledgeable in the development, review and appraisal of SOPs, validation, stability programs, manufacturing and laboratory operations for human and veterinary products. He is also knowledgeable in the preparation of Investigational drug applications. He assists clients in the development and preparation of drug master files, human and veterinary drug applications.

Who Should Attend?

Because of its comprehensive content, this program is directed toward management and personnel involved in preparing for, participating in and responding to FDA inspections and geared for laboratory, quality, compliance and regulatory professionals in the pharmaceutical, biopharmaceutical, biologics and allied industries with daily responsibilities in the following areas:

- Quality Control
- Quality Assurance
- Regulatory Affairs
- Validation Services
- Documentation and Technical Writing
- Product Submission
- Manufacturing
- Training
- GMP/GLP Compliance
- Product Submission
- Contract Laboratories
- Consultants
- Contract manufacturing


5875 Airport Road

Additional Information

Course Registration Fee For: "Compliance Chapter - Preparing & Hosting FDA Inspections Before, During and After” (Registration Fee $ 650.00 + GST) Certificate of Attendance: All participants will receive a certificate of attendance upon completion of the course Registration Fee Includes: Presentation Materials, Luncheon, Refreshments and Parking