2 Day Course: FDA Trends for Computer System Validation (CSV) Compliance and Enforcement (Boston, MA – June 25-26, 2018) – ResearchAndMarkets.com | Technology

This seminar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for Computer System Validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Areas Covered in the Session

Computer System Validation (CSV)System Development Life Cycle (SDLC) Methodology”GxP” – Good Manufacturing, Laboratory and Clinical Practices21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)Data Archival to ensure security, integrity and complianceValidation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processesPolicies and ProceduresCritical TrainingRecent FDA findings for companies in regulated industriesRecent trends in technology that need to be addressed in the CSV approachQ&A

Laura Wood, Senior Manager

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Drug Discovery,Pharmaceutical Manufacturing

KEYWORD: UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: TECHNOLOGY DATA MANAGEMENT HEALTH PHARMACEUTICAL FDA

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 05/15/2018 07:19 AM/DISC: 05/15/2018 07:19 AM

Copyright Business Wire 2018.

Source link

DPS Group Wins Contract in Sweden from AstraZeneca

As a result of winning this contract, DPS Group is now establishing an office in Sweden, which will be used initially to service AstraZeneca exclusively but later to service other clients in Sweden.  

DPS Group CEO Frank Keogh said: “DPS are delighted to have won this contract and we are confident the combination of a substantial local office and local partners in Sweden, as well as our large pharma centre of excellence offices in Dublin and Cork will ensure a quality and cost effective delivery model for AstraZeneca. As with all our clients we will work with AstraZeneca in a true partnership, building a long term relationship.”

The value of the contract has not been disclosed but it is expected that over 100 DPS engineering personnel potentially will be working on AstraZeneca projects depending on capital expenditure levels.

About DPS Group
DPS Group is a global engineering, consulting and project management company, serving high-tech industries around the world. DPS delivers services for clients across the complete engineering and construction value chain including feasibility studies, concepts, consulting, architecture, engineering, professional outsourcing, procurement, construction management, commissioning, qualification and validation; as well as contingent staffing solutions.

DPS applies its extensive Process Engineering expertise built over 40+years, as well as significant Lean Construction experience to assist our clients in high-end process sectors such as pharmaceuticals, biotech, medical devices and semiconductors. DPS deliver their manufacturing facilities speedily, safely and cost effectively. What sets us apart are the partnerships we build with our clients through a fundamental understanding of their businesses and our own agility, flexibility, original thinking and our high-calibre people.

We have grown substantially in recent years and now employ over 1,300 people in our offices and on client sites in Ireland, Netherlands, Belgium, Sweden, Israel, Singapore, Switzerland, the United Kingdom and the United States. For more information, visit https://ift.tt/2dvSn1u.

Contact: Annette O’Hara, Group Marketing Manager  
O +353-1-466-1755
M +353-87-248-2573
E annette.ohara@dpsgroupglobal.com

SOURCE DPS Group

Source link

AstraZeneca (AZN) Partnered with DPS Group in Sweden for Construction Contract

The UK researched-based biopharmaceutical company, AstraZeneca PLC (NYSE:AZN) partnered with DPS Group, the global and European based engineering, consulting and project management company, in a construction contract.

The contract is specific for AstraZeneca’s pharmaceutical site in Swedan.

The terms and condition of contract was not disclosed by both companies even the value, however, DPs Group said that it will provide Engineering, Procurement, Construction Management and Validation (EPCMV) services for all small and medium projects of AstraZeneca’s site in Swedan.

DPS Group serving to their clients with lean construction experience in pharmaceuticals, biotech, medical devices and semiconductors from over 40 years in US and Europe. With over 1,300 employees, the construction firm presently serving their customers in Ireland, Netherlands, Belgium, Sweden, Israel, Singapore, Switzerland, the United Kingdom and the United States.

After winning the construction contract from AstraZeneca’s, DPS Group said that it is now building its office in Swedan completely for AstraZeneca which will provide services to AstraZeneca on starting and later on for other clients.

“DPS are delighted to have won this contract and we are confident the combination of a substantial local office and local partners in Sweden, as well as our large pharma center of excellence offices in Dublin and Cork will ensure a quality and cost-effective delivery model for AstraZeneca. As with all our clients we will work with AstraZeneca in a true partnership, building a long-term relationship.” CEO of DPS Group, Frank Keogh, commented on the winning contract from AsrtaZeneca (AZN).

However, in other news for AstraZeneca, the biotech firm said that it will published its financial results for the first quarter of 2018 on Friday, May 18, 2018 on its website at 07:00 UK time.

A webcast for the financial results also will take place at 12:00 UK time on Friday, May 18, 2018.

With the $90.69 market value, AstraZeneca PLC (NYSE:AZN)’s shares up 0.05% or $0.02 cents to close the Monday trading session at $36.42. The biotech company posted EPS of $1.18 for the trailing twelve months.

Source link

AstraZeneca (AZN) Partnered with DPS Group in Sweden for Construction Contract

The UK researched-based biopharmaceutical company, AstraZeneca PLC (NYSE:AZN) partnered with DPS Group, the global and European based engineering, consulting and project management company, in a construction contract.

The contract is specific for AstraZeneca’s pharmaceutical site in Swedan.

The terms and condition of contract was not disclosed by both companies even the value, however, DPs Group said that it will provide Engineering, Procurement, Construction Management and Validation (EPCMV) services for all small and medium projects of AstraZeneca’s site in Swedan.

DPS Group serving to their clients with lean construction experience in pharmaceuticals, biotech, medical devices and semiconductors from over 40 years in US and Europe. With over 1,300 employees, the construction firm presently serving their customers in Ireland, Netherlands, Belgium, Sweden, Israel, Singapore, Switzerland, the United Kingdom and the United States.

After winning the construction contract from AstraZeneca’s, DPS Group said that it is now building its office in Swedan completely for AstraZeneca which will provide services to AstraZeneca on starting and later on for other clients.

“DPS are delighted to have won this contract and we are confident the combination of a substantial local office and local partners in Sweden, as well as our large pharma center of excellence offices in Dublin and Cork will ensure a quality and cost-effective delivery model for AstraZeneca. As with all our clients we will work with AstraZeneca in a true partnership, building a long-term relationship.” CEO of DPS Group, Frank Keogh, commented on the winning contract from AsrtaZeneca (AZN).

However, in other news for AstraZeneca, the biotech firm said that it will published its financial results for the first quarter of 2018 on Friday, May 18, 2018 on its website at 07:00 UK time.

A webcast for the financial results also will take place at 12:00 UK time on Friday, May 18, 2018.

With the $90.69 market value, AstraZeneca PLC (NYSE:AZN)’s shares up 0.05% or $0.02 cents to close the Monday trading session at $36.42. The biotech company posted EPS of $1.18 for the trailing twelve months.

Source link

CGMP Violations Found at India Facility

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

FDA sent a warning letter, dated April 24, 2018, to Goran Pharma Private Limited after an inspection of the company’s Sihor, Gujarat, India facility found deviations from current good manufacturing practices (CGMPs). A variety of violations found during the inspection included failure to identify ingredients from suppliers, inadequate quality control, and inappropriate equipment use. The inspection was conducted by FDA from Nov. 13–15, 2017.

Specifically, FDA stated in the warning letter that the company failed to test components from suppliers to “determine their conformance to identity, purity, strength, and other appropriate specifications. Your firm released components for use in drug product manufacturing based on certificates of analysis (COA) from your supplier without establishing the reliability of the suppliers’ analyses through appropriate validation.”

The agency requested the company provide a detailed description of how it plans on ensuring that components used in manufacturing be withheld from use until they have been tested. The company must also show how it will quality suppliers’ COAs, perform detailed risk assessments, and do a comprehensive review of laboratory practices, methods, equipment, and analyst competencies.

The warning letter also indicated that the company’s response to inspectors finding that inappropriate systems were used was lacking. The agency requested the company provide a detailed validation plan for its new system, procedures for routine monitoring of the system, a risk assessment of product manufactured on the old system, and reasons for why the company relied on past data to characterize the system’s state of control.

Inadequate control of air pressure, micro-organisms, dust, humidity, and temperature was also observed by inspectors. The agency requested the company provide an action plan for ensuring control and monitoring of temperature, humidity, and air cleanliness as well as an independent assessment of the company’s facilities and equipment.

The warning letter stated that FDA had placed the firm on Import Alert 66-40 on March 5, 2018.

FDA recommended the company hire a third-party CGMP consultant to audit the company’s operations.

Source: FDA

 

Source link