Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. The FDA has added a "Strategic Priorities" initiative that can assist companies to proactively address areas of GMP concern -- there are now two such reports 鈥� we will discuss both, emphasizing the latest 鈥渄raft for public comment鈥�, for 2014 - 2018. The reports reflect a major shift in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements. In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company's QA/RA and its senior management / staff.
This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Ongoing negative publicity on pharmaceuticals, devices, as well as events in unrelated industries show many senior executives just don't get it, and have put pressure on the Agency to "get tough on compliance / enforcement".
This webinar will trigger such a response by an examination / review of FDA's stated concerns for corporate cGMP compliance and public safety.
Areas Covered in the Session :
Major 鈥淒rivers鈥� and New U.S. FDA Initiatives
The FDA鈥檚 鈥淪trategic Priorities鈥� (1): 2011 鈥� 2014
The FDA鈥檚 鈥淪trategic Priorities鈥� (2): 2014 鈥� 2018
Major foreseeable problem areas for 2015 and beyond
Device, Pharmaceutical, Biological and Combination Products Issues
cGMP Issues - Strengthened Compliance
The Global Supply Chain
FDA's Life Cycle Requirements
Navigating through "Better Science"
A company gap analysis vis a vis FDA priorities
Correcting problem-prone areas
Interactive Q & A session
Who Will Benefit:
This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
Research & Development
Engineering Staff
Software Department
Quality Assurance
Regulatory Affairs
Manufacturing
Operations
cGMP instructors
Consultants
Mid-level and Senior Management
Personnel involved in verification and/or validation
Personnel involved in planning, execution and documentation
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1267
This change in focus has a major impact on interpretation of individual compliance objectives, cGMP objectives, and measurements of success. Ongoing negative publicity on pharmaceuticals, devices, as well as events in unrelated industries show many senior executives just don't get it, and have put pressure on the Agency to "get tough on compliance / enforcement".
This webinar will trigger such a response by an examination / review of FDA's stated concerns for corporate cGMP compliance and public safety.
Areas Covered in the Session :
Major 鈥淒rivers鈥� and New U.S. FDA Initiatives
The FDA鈥檚 鈥淪trategic Priorities鈥� (1): 2011 鈥� 2014
The FDA鈥檚 鈥淪trategic Priorities鈥� (2): 2014 鈥� 2018
Major foreseeable problem areas for 2015 and beyond
Device, Pharmaceutical, Biological and Combination Products Issues
cGMP Issues - Strengthened Compliance
The Global Supply Chain
FDA's Life Cycle Requirements
Navigating through "Better Science"
A company gap analysis vis a vis FDA priorities
Correcting problem-prone areas
Interactive Q & A session
Who Will Benefit:
This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
Research & Development
Engineering Staff
Software Department
Quality Assurance
Regulatory Affairs
Manufacturing
Operations
cGMP instructors
Consultants
Mid-level and Senior Management
Personnel involved in verification and/or validation
Personnel involved in planning, execution and documentation
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
For more information about this event please visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1267
