Overview:
You will understand how to use FDA warning letter responses for your own benefit. Learn from your mistakes and use this as an opportunity to improve your FDA inspections operations. Learn to set aside adequate time and/or expenses to insure your corrections are achievable. Use these observations as a learning experience and improve your operations. Learn to accept constructive criticism and how to turn it around into a positive thing.
Why Should You Attend:
This webinar will insure that you do not rush to send out a poorly written response to an FDA 483 inspection. Preparing a detailed and sincere written response to FDA-483 Observations and Warning Letters could prevent you from receiving a Warning Letter or worse - getting placed on Import Alert.
You will learn how to best compose these responses to FDA and prevent serious loses or complete work stoppage. A poor written response could prevent any review of your applications and supplements.
Hopefully, you were prepared for this regulatory inspections. It is even more important to compose a comprehensive response that appeases FDA. This response will also assist your firm in correcting these potentially serious problems and help to improve your quality operations.
Areas Covered in this Webinar:
This webinar will include reasons why you should prepare a team focused on writing the best response. Include others that were not directly involved in FDA’s inspections so they are not biased or angry. You will learn why it is crucial that your letter is written with correct grammar and usage since many people are not familiar with English as their first language.
Do not go overboard and promise corrections or changes that may be too expensive and not necessary. Learn that it is acceptable to point out a mistake in an observation so you will not waste valuable time or money responding to an error. Using these responses to update and correct old procedures will help you to increase your compliance with regulations. Learn to be open to changes that will serve to support your continuous compliance initiatives.
Learn how to gauge the amount of time to complete these projects and prioritize your commitments with achievable timelines. Consider the big picture and insure your responses are achievable. Consider the budget needed and prepare for the time and expenses to complete these projects.
Learning Objectives:
• Prepare a team focused on writing the best response
• Learn that it is acceptable to point out a mistake in an observation
• Learn how to gauge the amount of time to complete these projects
Who Will Benefit:
• Pharmaceutical Manufacturers (Quality Assurance, Quality Control, Regulatory Affairs and Facilities/ Maintenance Groups)
• API Manufacturers
• Contract Manufacturing Organizations
• Contract Testing Laboratories
• Research and Development Groups
• Virtual Companies
For more information, please visit : https://www.complianceglobal.us/product/700565/BrianGNadel/responding-to-fda-483s-and-warning-letters/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.
Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.
Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA's Center for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.
Mr. Nadel holds a Bachelor’s degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.
You will understand how to use FDA warning letter responses for your own benefit. Learn from your mistakes and use this as an opportunity to improve your FDA inspections operations. Learn to set aside adequate time and/or expenses to insure your corrections are achievable. Use these observations as a learning experience and improve your operations. Learn to accept constructive criticism and how to turn it around into a positive thing.
Why Should You Attend:
This webinar will insure that you do not rush to send out a poorly written response to an FDA 483 inspection. Preparing a detailed and sincere written response to FDA-483 Observations and Warning Letters could prevent you from receiving a Warning Letter or worse - getting placed on Import Alert.
You will learn how to best compose these responses to FDA and prevent serious loses or complete work stoppage. A poor written response could prevent any review of your applications and supplements.
Hopefully, you were prepared for this regulatory inspections. It is even more important to compose a comprehensive response that appeases FDA. This response will also assist your firm in correcting these potentially serious problems and help to improve your quality operations.
Areas Covered in this Webinar:
This webinar will include reasons why you should prepare a team focused on writing the best response. Include others that were not directly involved in FDA’s inspections so they are not biased or angry. You will learn why it is crucial that your letter is written with correct grammar and usage since many people are not familiar with English as their first language.
Do not go overboard and promise corrections or changes that may be too expensive and not necessary. Learn that it is acceptable to point out a mistake in an observation so you will not waste valuable time or money responding to an error. Using these responses to update and correct old procedures will help you to increase your compliance with regulations. Learn to be open to changes that will serve to support your continuous compliance initiatives.
Learn how to gauge the amount of time to complete these projects and prioritize your commitments with achievable timelines. Consider the big picture and insure your responses are achievable. Consider the budget needed and prepare for the time and expenses to complete these projects.
Learning Objectives:
• Prepare a team focused on writing the best response
• Learn that it is acceptable to point out a mistake in an observation
• Learn how to gauge the amount of time to complete these projects
Who Will Benefit:
• Pharmaceutical Manufacturers (Quality Assurance, Quality Control, Regulatory Affairs and Facilities/ Maintenance Groups)
• API Manufacturers
• Contract Manufacturing Organizations
• Contract Testing Laboratories
• Research and Development Groups
• Virtual Companies
For more information, please visit : https://www.complianceglobal.us/product/700565/BrianGNadel/responding-to-fda-483s-and-warning-letters/1
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile:
Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.
Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.
Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA's Center for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.
Mr. Nadel holds a Bachelor’s degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.
