Regulatory NewsRegulatory News
OIG report highlights shortcomings in FDA’s IT acquisition procedures
Posted 18 January 2023 By Ferdous Al-Faruque
The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) is calling on the Food and Drug Administration (FDA) to improve its processes for buying information technology (IT). Overall, the oversight agency de...
Regulatory NewsRegulatory News
FDA cites Sun Pharma with litany of GMP violations, including poor aseptic practices
Posted 11 January 2023 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) admonished Sun Pharmaceutical Industries in a recent warning letter for a several good manufacturing practice (GMP) violations, including poor aseptic practices, inadequate cleanroom design and e...
Regulatory NewsRegulatory News
FDA revises guidance on responding to ANDA complete response letters
Posted 16 December 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has revised its guidance on timeframes for responding to complete response letters (CRL) to abbreviated new drug applications (ANDA) based on commitments in the latest generic drug user fee progr...
Regulatory NewsRegulatory News
MDCG offers clarity on ‘hybrid’ audits under MDR, IVDR
Posted 06 December 2022 By Ferdous Al-Faruque
The European Commission’s Medical Device Coordination Group (MDCG) has adopted a definition for “hybrid audits” that offers notified bodies flexibility in terms of how long an auditor is physically present on the auditee’s premises for a...
This Week at FDAThis Week at FDA
This Week at FDA: Guidance tsunami continues, questions about FDA’s accelerated approval pathway
Posted 21 October 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The US Food and Drug Administration (FDA) has co...
This Week at FDAThis Week at FDA
This Week at FDA: It’s raining user-fee guidances, Hallelujah!
Posted 07 October 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The big news this week is the firehose of guidan...
Regulatory NewsRegulatory News
Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Posted 28 September 2022 By Joanne S. Eglovitch
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, ques...
Regulatory NewsRegulatory News
Warning letters: Investigators refused entry to testing lab; firm cited for distributing unauthorized COVID tests
Posted 31 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) chastised a San Diego, California based testing lab in a recent warning letter for “significant deviations” from current good manufacturing practices (GMPs), including initially blocking investig...
Regulatory NewsRegulatory News
FDA warning letter tells Spanish API firm to up its validation game
Posted 22 July 2022 By Joanne S. Eglovitch
A Spanish producer of active pharmaceutical ingredients (API) was chastised by the US Food and Drug Administration (FDA) in a June 30 warning letter for its spotty approach to validation and ensuring that manufacturing processes remain...
Regulatory NewsRegulatory News
Stakeholders seek tweaks to FDA’s voluntary improvement program guidance
Posted 08 July 2022 By Jeff Craven
The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to know mor...
Regulatory NewsRegulatory News
FDA tells Dutch API producer to clean up its equipment act
Posted 01 July 2022 By Joanne S. Eglovitch
A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Admin...
Regulatory NewsRegulatory News
ICMRA explores hybrid inspections, postapproval changes with new pilots
Posted 29 June 2022 By Joanne S. Eglovitch
A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.  
     
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In-PersonIn-Person
Survivor: The FDA 510(k) Program Edition
Thursday, 20 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Price: Member $1340| Nonmember $1570
2-day, in-person workshop, regulatory experts to review the current requirements & expectations of this evolving program and provide strategies to help ensure success when navigating the FDA 510(k) program
In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM) 0.0 RAC Credits For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
New York / New Jersey & DC/ Baltimore Chapters: An FDA Review and What's Next for Regulatory Professionals in 2023
Tuesday, 28 February 2023 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 | Nonmembers: $25
This webinar provides an overview of the significant FDA action in 2022, and helps regulatory professionals identify important areas of focus for 2023.
Virtual ProgramsVirtual Programs
Considerations in Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This webcast will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
DC/ Baltimore Chapter: FDA Compliant Use of Smartphones, Apps and Technology in Clinical Trials
Wednesday, 22 February 2023 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0| Nonmember: $25
Use of wearable devices and smart technology is increasing in clinical trials. This program will discuss the use of Smartphones, Apps and other technology in terms of FDA compliance and practical concerns
Virtual ProgramsVirtual Programs
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling
Tuesday, 14 March 2023 (12:00 - 1:00PM) 1.0 RAC Credits Free
In this webinar, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.

Books   |   Learning

On-demandOn-demand
Most Common Findings in EU Clinical Evaluations (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Learn the most common findings identified by Notified Bodies and by Qserve when performing a final CER review to the requirements of the MDR and MEDDEV 2.7/1 rev.4.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Regulation of Generic Drugs in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of the legal and regulatory structure of generic drugs in the US.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Medical Devices: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is intended to provide a basic overview of US medical device regulation.
On-demandOn-demand
Mastering your 510(k) submission process (On-Demand)
1.0 RAC Credits
Member: $0 | Nonmember: $25
Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
FDA Law and Regulation [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides an overview of FDA and its associated laws and regulations.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Pharmaceuticals: Compliance & Audits [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides knowledge of fundamental, high-quality auditing practices and skills.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
REMS and RMPs [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides an overview of the history of risk management, reviews risk management philosophies and examines regulatory requirements and interactions between industry and regulators in the US, EU and Canada
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Medical Devices: Compliance & Audits [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is designed for quality and regulatory professionals with little or no previous auditing experience and individuals who need to broaden their knowledge of the audit process.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Regulation of Combination Products [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides a historical perspective on combination product regulation in the US, and examines the current regulations and policies covering the identification, jurisdiction and review of combination product
On-demandOn-demand
Sponsored Webcast: Orphan Drug Designation | The Considerations, The Rewards, and How They Differ Between The US and Europe (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why
On-demandOn-demand
Sponsored webcast: Quality vs. compliance: moving beyond standards (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why
BooksBooks
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
     
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RAC ExamRAC Exam
RAC Devices Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Devices Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Devices Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
RAC ExamRAC Exam
RAC Drugs Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Drugs Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Drugs Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM)
For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
In-PersonIn-Person
Survivor: The FDA 510(k) Program Edition
Thursday, 20 April 2023 (9:00 - 4:00PM)
12.0RAC Credits
Price: Member $1340| Nonmember $1570
2-day, in-person workshop, regulatory experts to review the current requirements & expectations of this evolving program and provide strategies to help ensure success when navigating the FDA 510(k) program
Virtual ProgramsVirtual Programs
Considerations in Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $175 | NonMember: $200
This webcast will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling
Tuesday, 14 March 2023 (12:00 - 1:00PM)
1.0RAC Credits
Free
In this webinar, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
New York / New Jersey & DC/ Baltimore Chapters: An FDA Review and What's Next for Regulatory Professionals in 2023
Tuesday, 28 February 2023 (12:00 - 1:00PM)
1.0RAC Credits
Member: $0 | Nonmembers: $25
This webinar provides an overview of the significant FDA action in 2022, and helps regulatory professionals identify important areas of focus for 2023.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
DC/ Baltimore Chapter: FDA Compliant Use of Smartphones, Apps and Technology in Clinical Trials
Wednesday, 22 February 2023 (11:00 - 12:00PM)
1.0RAC Credits
Member: $0| Nonmember: $25
Use of wearable devices and smart technology is increasing in clinical trials. This program will discuss the use of Smartphones, Apps and other technology in terms of FDA compliance and practical concerns
On-demandOn-demand
Mastering your 510(k) submission process (On-Demand)
1.0RAC Credits
Member: $0 | Nonmember: $25
Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
On-demandOn-demand
Sponsored Webcast: Orphan Drug Designation | The Considerations, The Rewards, and How They Differ Between The US and Europe (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why