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BrainStorm Central Consulting LLC

BrainStorm Central Consulting LLC

Richmond,VA
  • 245

About Company

BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.


"Our experience will lead you to us, your experience will keep you coming back..."


FDA Compliance Training Topics Offered:

• Developing a Strategic Approach to FDA Compliance for Computer Systems

• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

• Medical Device Industry Trends for Computer Systems Regulated by FDA

• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA

• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

• FDA Compliance and Mobile Applications

• Good Documentation Practices to Support FDA Computer System Validation

• In-Depth Computer System Testing of Computer Systems Regulated by FDA

• Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

• Data Integrity and Governance for Computer Systems Regulated by FDA

• Trends in FDA Compliance and Enforcement for Regulated Systems

• Best Practices in Preparation for an FDA Computer System Audit

• Functional System Requirements for Computer Systems Regulated by FDA

• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA

• C-TPAT Compliance for FDA-Regulated Industries

• Medical Device Cybersecurity and FDA Compliance

• 21st Century Cures Act and Medical Device Software Compliance

• Medical Device Software 62304 Compliance

• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems

• Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

There are no Webinars available in Section.

Good Documentation Practices to Support FDA Computer System Validation
PREMIUM
premium
In-Depth Testing of Computer Systems Regulated by FDA
PREMIUM
premium
In-Depth Testing of Computer Systems Regulated by FDA
  • Accountant
  • CPA (CA)
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
Trends in FDA Compliance and Enforcement for Regulated Systems
PREMIUM
premium
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
PREMIUM
premium
Best Practices in Preparation for an FDA Computer System Audit
PREMIUM
premium
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
PREMIUM
premium
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
  • Accountant
  • CPA (CA)
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
Register
  • 4
  • (1)
Data Integrity and Data Governance for Computer Systems Regulated by FDA
PREMIUM
premium
Data Integrity and Data Governance for Computer Systems Regulated by FDA
  • Accountant
  • CPA (CA)
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
Register
  • 4.5
  • (6)

4.7

  • 4.7

(61) Ratings

Excellent

50

Very Good

8

Average

3

Poor

0

Terrible

0

MR

Michael Ricozzi, CPA (US)

May 20th 2022

instructor appeared to be an expert in this area .. great info

JR

John Richmond, CPA (US)

Apr 7th 2022

great session

DB

David Brady, CPA (US)

Apr 7th 2022

Instructor was obviously very knowledgeable. She covered a huge amount of ground of a very technical subject matter.

MEM

Mary Ellen Morris, CPA (US)

Apr 7th 2022

This was an outstanding detail presentation I'm a very complicated topic

LH

Linda Hagedorn, CPA (US)

Mar 30th 2022

The presentation was excellent, highlighting opportunities for discovering accidental or willful fraud, and the perspective of being the auditor and auditee.

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