Description:-

In FDA-regulated industry, it is imperative that firms should be well aware of the recent policy changes and understand what laws and regulations apply for FDA-regulated products on the US market (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics).

This conference is intended to discuss FDA policy changes including the changes for FDA inspection in 2019 under the new political environment. This presentation is further intended to help the industry prepare better and manage an FDA inspection more proactively and effectively.  The speaker will share his actionable tips and advice in view of the recent FDA policy changes in 2019.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.  

This presentation will provide great opportunities to become familiar with what lessons we can learn from FDA enforcement and inspection practices.

The speaker will share his PASS-IT recommendation/suggestions – dos and don’ts. 

Areas To Be Covered:-

• Laws and Regulations
• 2019 FDA Policy Changes
• FDA Inspection Manuals
• FDA Inspection Types and Depth of Inspection
• How to Avoid Common Deficiencies
• Actionable Inspection Preparation and Management
• Communication with EQ Skills
• Employee Training
• Actual Case Studies
• Speaker’s PASS-IT Suggestions/Recommendations-Dos and Don’ts
• Conclusion

Who Will Benefit:-

• CEOs
• VPs
• Compliance Officers
• Attorneys
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the FDA Drug Review and Approval Processes

Description:-

In FDA-regulated industry, it is imperative that firms demonstrate adequate implementation of Excel Spreadsheet validations compliant with FDA expectations/requirements, 21 CFR Part 11 (Part 11) applicable to manufacturers for drugs, biologics/biosimilars and medical devices including IVDs. 

This conference will help firms to understand the compliance requirements better to adequately develop and implement the requirements for Excel spreadsheets used in GMP environment under Part 11 and computer system validation.  Adequate implementation of Excel spreadsheets for Part 11 compliance will ensure the quality and integrity of GxP data and avoid FDA enforcement actions leading to 483s and warning letters.

FDA frequently states “failure to maintain complete data; failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; “failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system….”

This conference will provide excellent opportunities to check your current practices and also to ensure your compliance for part 11 requirements and computer system validation for Excel spreadsheets of GxP data.

Areas To Be Covered in this Seminar:-

• Applicable Statute(s) and Regulations
• Definitions
• GMP Requirements for Software
• Requirements for Excel Spreadsheets under 21 CFR Part 11
• Excel Spreadsheets for GxP Data
• FDA Enforcement Actions on the Excel Spreadsheets
• How to Avoid FDA 483s and Warning Letters
• Excel Spreadsheet Validation
• Computer System Validations
• Excel Data Validations
• Requirements for Excel Audit Trails
• Excel Validation Documentation Requirements
• PASS-IT Recommendations: Best Practices

Who will Benefit:-

• CEOs
• VPs
• Compliance Officers
• Attorneys
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the FDA Drug Review and Approval Processes