Activity
My Events (38)
http://pickevent.com/Compliance4all

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Upcoming events:

Compliance4all created an event

WEBINAR

MAY

15

10:00 AM

Building a Sustainable Vendor Qualification Program

online event, Fremont, CA, USA

This program will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors. Overview:  Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing...

Building a Sustainable Vendor Qualification Program
On-site and off-site verifications
FDA regulated products
fda compliance training
Compliance4all created an event

WEBINAR

MAY

19

10:00 AM

Managing FDA After a Bad Inspection

online event, Fremont, CA, USA

Overview:  The webinar explains how the FDA conducts an inspection and collects evidence to show you failed to meet one or more regulatory requirement. How you respond to the inspection makes a big difference in the FDA's follow up with you. The agency follows well establish procedures for how it evaluates an inspection and uses a number of factors to determine what action it might take after a bad inspection.. If you understand what the FDA does with your inspection results, you may be able to mitigate the financial and marketing damage. You should understand what your competitors may do...

FDA's inspection strategy
fda compliance training
compliance training
Compliance4all created an event

WEBINAR

MAY

21

10:00 AM

Does Anyone Care About SOX Anymore?

online event, Fremont, CA, USA

Overview:  Attend this presentation and find out what the SEC is watching closely for now and into the future. Like it or not, the SEC is still fining companies and filing criminal charges against company executives. Don’t be one of them. Why should you Attend: Do you get the feeling that the only one who really cares about SOX anymore is the internal auditor? Does the SEC even care? The answer is that the SEC is watching more closely than ever and you need to be even more careful.  Areas Covered in the Session: Is the SEC catching anyone these days? What are the key items the SEC...

SOX
SOX compliance webinar
compliance training
Compliance4all created an event

WEBINAR

MAY

22

10:00 AM

FDA Inspections - Do's and Don'ts

online event, Fremont, CA, USA

Overview:  Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency. Why should you Attend: If you are looking for answers to these questions, you would certainly benefit by...

FDA Inspections
fda compliance training
fda inspection training
Compliance4all created an event

WEBINAR

MAY

26

10:00 AM

Developing and Using the Product Risk Management File & Report

online event, Fremont, CA, USA

Overview:  Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned executed, and visibility maintained. There is a failure to fully utilize the power of...

Risk Management File & Report
Product Hazard Analysis
Risk Management
Training
Compliance4all created an event

WEBINAR

MAY

26

10:00 AM

Food Allergen Programs

online Event, Fremont, CA, USA

Overview:  Attend this webinar to understand the purpose of cleaning validation. The training session will focus on how to develop a cleaning validation plan related to food allergens, including the sequence of events likely to proceed in a cleaning validation plan, which can be tailored for specific situations. Participants will understand what to consider when choosing sampling and testing methods. The session will provide useful example scenarios to demonstrate effective cleaning regime and non-effective cleaning regime depending on the acceptable level. On completion of the training,...

Food Allergen Programs
Validation of Cleaning Procedures
purpose of cleaning validation
fda compliance training
Compliance4all created an event

WEBINAR

MAY

28

10:00 AM

Establish and Maintain an Effective Supplier Qualification Program

online Event, Fremont, CA, USA

This session will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs. Overview:  FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns. FDA has the right to see certain elements of your supplier qualification/purchasing controls...

Effective Supplier Qualification Program
vendor management qualification programs
fda
compliance
training
Compliance4all created an event

WEBINAR

JUN

02

10:00 AM

Using the ISP98 Model Forms for Standby Letters of Credit

online event, Fremont, CA, USA

This webinar will acquaint participants with the ISP98 Model Forms and thereby prepare them to structure letters of credit that comply with the provisions of the ISP98. The program will focus on how and when to use the model forms to accomplish such objectives as automatic extensions, automatic reductions, transfer of drawing rights, confirmation, and arranging local guarantees.  Why should you Attend: Understand the bare essential requirements for a well-written letter of credit Explore repercussions of poor language Develop templates and boilerplates for use in common situations ...

Standby Letters of Credit
ISP98 Model Forms
International Standby Practices
Compliance training
Compliance4all created an event

WEBINAR

JUN

03

10:00 AM

Supplier Quality Management - Implement it Now or Pay for it Later

online EVent, Fremont, CA, USA

This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for Supplier Quality Management that will satisfy the FDA's requirements without creating undue burdens for the organization.  Learning Objectives: Understand the FDA's requirements for medical device supplier assessment and approvals. "Who" are considered to be suppliers? How to structure a Supplier Quality Agreement What are the potential methods for evaluating and assessing suppliers? Areas Covered in the Session: Supplier Quality...

Supplier Quality Management
medical device manufacturer.
Fda Compliance for Medical device
Compliance4all created an event

WEBINAR

JUN

03

10:00 AM

How to Respond to an FDA Investigation: What happens when the FDA threatens to shut you

online Event, Fremont, CA, USA

Overview:  An FDA investigation can lead to observations requiring remediation, disruption of your business, loss of revenue and enforcement actions up to and including having your plant shutdown. Come learn from someone who's "been there and done that" having gone through an intense FDA investigation with a global manufacturer of durable medical equipment that resulted in the imposition of a Consent Decree and plant shutdown. Take-aways will include practical tips on how to interact with the FDA and create sustainable corrective actions. Why should you attend: How would you respond to an...

FDA Investigation
fda compliance training
fda training
Compliance4all created an event

WEBINAR

JUN

08

10:00 AM

Conducting Observational Studies in US, Canada and Europe

online event, Fremont, CA, USA

Overview:  This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada. Some guidelines have been developed and others are in the process of being developed. In some jurisdictions clinical trials are differentiated from observational studies. Conducting such studies retrospectively or prospectively can have a different requirement from a regulatory perspective. The same study done in different jurisdictions will follow different regulatory pathways. Working through this confusing environment is very difficult.  Areas...

Observational Studies
prospective observational studies
retrospective observational studies
Compliance4all created an event

WEBINAR

JUN

08

10:00 AM

Quality by Design: Establishing a Systematic Approach to Pharmaceutical Development

online Event, Fremont, CA, USA

Overview:  This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Learn How to: Implement QbD principles from discovery through product...

Pharmaceutical Development
ICH guidance document on pharmaceutical development
QbD principles
Compliance4all created an event

WEBINAR

JUL

07

10:00 AM

Canadian Establishment Licenses: Drugs, Supplements and Medical Devices

Online Event, Fremont, CA, USA

Overview:  Overview of the different licenses for sites involved with exporting, importing and manufacturing of drugs, natural health products and medical marijuana to be provided. Specific focus will be on which information is required for the various types of facility licenses, for both Canadian and non-Canadian buildings involved in the pharmaceutical product supply chain. Sourcing of active pharmaceutical ingredient sources (API) must now be covered in some types of licensing, details will be provided on API requirements with examples using Health Canada’s required application...

Canadian Establishment Licenses
Drugs
Supplements and Medical Devices
Consumer goods
webinar
Compliance4all created an event

WEBINAR

JUL

09

10:00 AM

International Regulatory Cooperation Among Agencies

Online Event, Fremont, CA, USA

This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. Overview:  It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made. Examples of shared experiences with orphan drugs, cough and cold medications, generic drugs and GMP inspections. We will discuss Tier 1, 2, 3, and other regulatory agencies and how the approach to international reviews varies from agency to agency. We will discuss whether the European...

International Regulatory Cooperation
regulatory agencies
Inspections and GMP
Compliance4all created an event

WEBINAR

JUL

14

10:00 AM

Supply-Chain Finance

Online Event, Fremont, CA, USA

Overview:  It seems the latest and greatest technique for creating business efficiencies is "supply-chain management." An important component of this is supply-chain finance. So what, exactly, is "supply-chain finance"? Although the term has been applied in a wide range of contexts, it has particular application to structures in which a bank provides financing to the suppliers of a bank customer. While the concept has roots in letters of credit and forfaiting, it is a new approach and is still mutating. Variations are known as "reverse factoring" and "approved invoice financing" and may...

Supply-Chain Finance
supply-chain management
Letters of credit
Compliance4all created an event

WEBINAR

JUL

14

10:00 AM

Pest Control in Food Processing and Foodservice

online Event, Fremont, CA, USA

Overview:  Effective sanitation in the food industry involves the maintenance of clean conditions in the entire food operation including the control of pests such as cockroaches, houseflies, rats, mice, and birds. This status is attained through the prevention of pest entry and eradication of those that infiltrate food establishments. As the food processing and foodservice industry have grown, methods of food production, processing, distribution, and preparation have changed. Increased processing and food preparation have included more prepackaged food as partially or fully prepared bulk...

Pest Control in Food Processing
Effective sanitation in the food industry
Effective pest control practices
Compliance4all created an event

WEBINAR

JUL

15

10:00 AM

Coliform 649 -The Coliform Lottery

online event, Fremont, CA, USA

Overview:  Although the use of coliforms as an indicator for water quality and safety has been recognized for >100 years, our reliance on coliform numbers as the primary indicator for water quality and safety is misguided. Our concept of water potability needs to be redefined, as does our reliance on traditional microbial indicators of potability. We need to consider other approaches. Why should you Attend: Learn why coliforms are now no longer considered as the primary indicator of water potability. Learn about other indicator organisms and how to interpret their detection. Learn about...

Coliform 649
The Coliform Lottery
Waterborne pathogens
Compliance4all created an event

WEBINAR

JUL

16

10:00 AM

Aerospace - AS9100 vs ISO 9001

online event, Fremont, CA, USA

Overview:  AS9100 was released in 1999, and was based on ISO 9001. As many different organizations wanted a standard for their industry, ISO 9001 did not cover all of the aspects needed to ensure safe materials and manufactured goods were acceptable for their aerospace applications. AS9100 takes the ISO 9001 requirements and supplements them with additional quality system requirements, which are established by the aerospace industry in order to satisfy DOD, NASA and FAA quality requirements. The intent of AS9100 is to establish a single quality management system for use within the...

AS9100 vs ISO 9001
difference between AS9100 vs ISO 9001?
ISO 9001 requirements
Compliance4all created an event

WEBINAR

JUL

21

10:00 AM

TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties

online Event, Fremont, CA, USA

Join us for a content-rich 90-minutes and you will gain the tools to make you the most effective information return manager your company has ever seen. Overview:  Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements. Understand the difference between and 1st and 2nd B-Notice and the related differences in required vendor responses. Be sure you institute and stop Backup...

TIN Matching
Best practices for managing 1099 reporting requirements
Compliance4all created an event

WEBINAR

JUL

21

10:00 AM

Resiliency Individual, Community, Business

online event, Fremont, CA, USA

Overview:  Business Continuity Management (BCM) is a holistic management process that identifies potential impacts that threaten an Organization and provides a framework for building resilience with the capability for an effective response that safeguards the interests of its key stakeholders, reputation, brand and value creating activities. This encompasses the management of recovery or continuity in the event of a disaster as well as the management of the overall program through training, rehearsals, and reviews, to ensure the plan stays current and up to date. The Business Continuity...

Business Continuity Management
Business Continuity Management Program
holistic management process
Compliance4all created an event

WEBINAR

JUL

30

10:00 AM

The Enigma of a Healthy Diet

online event, Fremont, CA, USA

Overview:  This webinar will raise awareness about the risks associated with consuming raw produce and the limitations of current intervention strategies. The difficulty of developing and validating reliable analytical approaches will also be discussed. There is need for reliable data to address public health issues associated with produce. There are no harmonized criteria or method classification system to assist laboratories in choosing appropriate methods. Why should you Attend: Learn about the risks associated with consuming raw produce and the limitations of intervention strategies...

The Enigma of a Healthy Diet
Microbial Contamination
Compliance4all created an event

WEBINAR

JUL

30

10:00 AM

Introduction to Bioresearch Monitoring

online event, Fremont, CA, USA

Overview:  FDA's bioresearch monitoring program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas. Regulations addressing requirements of clinical investigators, sponsors and monitors of human drugs and biologics studies (21 CFR Parts 312 and 314) were published on March 19, 1987, and became effective on June 17, 1987. The animal...

Introduction to Bioresearch Monitoring
FDA's bioresearch monitoring program
FDA regulations

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Past events:

Compliance4all created an event

WEBINAR

MAY

13

10:00 AM

Metrology: Statistical Analysis of Measurement Uncertainty

online event, Fremont, CA, USA

Overview:  The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R; (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias. The webinar ends with an explanation of how to combine all relevant...

Measurement Uncertainty
Measurement Uncertainty training program
compliance training
Compliance4all created an event

WEBINAR

MAY

12

10:00 AM

Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements

online Event, Fremont, CA, USA

This Webinar will provide a broad overview of the requirements and expectations and an introduction to the regulations, including 21 CFR 1, Subpart E-Imports and Exports. Entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. Product information should include device name and product code. The affirmation of compliance should include: importer registration number, foreign establishment registration number and name of U.S. agent, medical device listing number, and Premarket Notification 510(k) or...

Importing and Exporting Medical Devices
FDA regulatory requirements
Regulatory Affairs
Compliance4all created an event

WEBINAR

MAY

12

10:00 AM

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

online event, Fremont, CA, USA

This interactive program will examine the existing and proposed requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 (j) - including its derivative documents, the DMR and DHR.   One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier. Currently they...

Design History File
Compliance training
Medical Records device
Compliance4all created an event

WEBINAR

MAY

06

10:00 AM

Traffic Flow Management (TFM) Operations-End to End Flight Scenario

online event, Fremont, CA, USA

This session, one in a series of ATC topics, addresses the operational environment and functioning of ATC System Command Center (ATCSCC). Overview:  The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay. To draw the entire ATC series together, the webinar...

Traffic Flow Management
ATCSCC operations
Radar data acquisition
Flight data acquisition
Compliance4all created an event

WEBINAR

MAY

05

10:00 AM

Foreign Bodies in Foods - Effective Techniques for Prevention, Control and Detection

online event, Fremont, CA, USA

Attend this webinar to understand all reasonable precautions necessary for the prevention and control of foreign bodies in food. The training will focus on how to use the due diligence defense and what is required to demonstrate this defense. This training will assists participants or companies of all sizes in the selection of relevant methods used to prevent and control foreign bodies in foods. This session will discuss what to do when a foreign body incident has occurred. This will include useful and relevant example scenarios. On completion of the training, the participants will be able to...

Food Safety Modernization Act
How to manage foreign bodies incidents
The role of HACCP system
Compliance4all created an event

WEBINAR

MAY

05

10:00 AM

Contract Killer Clauses in Construction: And How to Neutralize Them

online event, Fremont, CA, USA

Overview:  The most important and egregiously written construction contract clauses have been shown to cost a 20% premium on prices and lead to fail projects and litigation. What are examples of poorly drafted killer clauses and how can you avoid them to get better project results. Hear from Brian Perlberg who is counsel to a coalition effort called ConsensusDocs which includes the endorsement of 40+ leading design and construction associations to draft best practice contracts that allocate risk fairly to the party that is in the best position to control and mitigate risk with the goal of...

Contract Killer Clauses in Construction
construction contracts
construction process
Compliance4all created an event

WEBINAR

APR

15

10:00 AM

Change Control - Key to Successful cGMP Compliance

online event, Fremont, CA, USA

Overview:  There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems. Control and review of device changes are a major requirement in determining...

Change Control
cGMP Compliance
Regulatory and Compliance Trainings
Online Compliance training
Compliance regulatory training
Compliance4all created an event

WEBINAR

APR

14

10:00 AM

Conducting Successful Product Complaint Investigations

online event, Fremont, CA, USA

Overview:  An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design,...

Regulatory and Compliance Trainings
Compliance regulatory training
Online Compliance training
Compliance4all created an event

WEBINAR

APR

14

10:00 AM

Food Safety and Quality Planning

Online Event, Fremont, CA, USA

Overview:  America's food supply is occasionally described as "the safest in the world" yet the recalls continue. This session focuses on how to combine food quality and food safety planning into a single team exercise that allows the identification and definition of controls that cover HACCP on the food safety side while assuring the quality and shelf life of delivered product. Planning activities are generally considered preventive in nature. It is somewhat naïve to separate quality from food safety since quality foods must be considered safe in order to meet most definitions of...

Food Safety
Quality Planning
Regulatory and Compliance Trainings
Compliance regulatory training
Compliance4all created an event

WEBINAR

APR

14

10:00 AM

FDA's Legal Hold on Your Mobile Apps

Online Event, Fremont, CA, USA

Overview:  The use of mobile apps has increased dramatically year after year. The sophistication of the platform technology, e.g., cell phone, creates huge opportunity for software application. A sensor plugged into your cell phone can be used as a stethoscope. How the platform and software are integrated becomes a significant regulatory issue for the FDA. In addition to an app being safe and effective, this type of device requires the design and implementation of preventive measures to ward off cyber-intrusions. The portals of attack with the use of mobile apps and wireless technology...

fda regulation
fda compliance
compliance training
regulatory training
fda compliance training
Compliance4all created an event

WEBINAR

APR

10

10:00 AM

Building a Validation Program From Top to Bottom

online event, Fremont, CA, USA

Overview:  Companies face many common issues or confusions that arise while creating a validation program such as, Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ). Sometimes matrix approach to cleaning validation has gaps or even worse customer or 483 audit findings due to the program's near impossibility to manage. How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment...

PLC-based systems
FDA
Compliance
Training
Fda compliance
Compliance4all created an event

WEBINAR

APR

09

10:00 AM

Quality System Regulations for Devicemakers: A Regulatory Approach

Online Event, Fremont, CA, USA

Overview:  FDA's findings of the companies Quality System deficiencies fall into a multitude of errors or deficiencies including change control, employee errors, Corrective and Preventive Action (CAPA) and consistent process control as demonstrated through validation and incident tracking systems. The average cost of a Warning Letter remediation effort is estimated at US $750,000 or millions dependent on the product and the identified deficiencies in order to correct the FDA identified deficiencies including added resources for consultants, personnel, remediation of legacy records, etc....

Quality System Regulations for Devicemakers
FDA 510(k)
Quality Systems compliance
risk-management strategy
Online Compliance training
Compliance regulatory training
Compliance4all created an event

WEBINAR

APR

09

10:00 AM

Food Safety - Food Defense

online event, Fremont, CA, USA

Overview:  Since the Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to. These requirements mandate FDA’s action in the area of Food Defense, and penalties continue to go higher and higher. With the associated costs related to oversights and recalls, Food Defense is an important economic aspect of any organization. This session is designed for food manufacturers, packagers and handlers and is focused towards helping both domestic and foreign entities in ensuring compliance with...

Food Safety
Food Defense
Food Safety Modernization Act
Fda compliance training
Compliance regulatory training
Regulatory and Compliance Trainings
Compliance4all created an event

WEBINAR

APR

09

10:00 AM

Quality System Regulation: Production and Process Controls Subsection

Online Event, Fremont, CA, USA

Overview:  Participation in this webinar will enhance the attendees’ perceptions, interaction skill sets, and provide support to help convince the management team that regulatory professionals are not roadblocks or impediments to the organization. Areas Covered in the Session: Issues facing the regulatory professional What needs to happen The Five Phases of Regulatory "Strategic Alignment" Regulatory Mission and Vision Regulatory Values and Beliefs Who Will Benefit: Regulatory Management Regulatory Professionals Executive Management Legal Professionals Quality Management ...

Quality System Regulation
Strategic Alignment
Compliance regulatory training
Regulatory and Compliance Trainings
FDA Compliance
Compliance4all created an event

WEBINAR

APR

09

10:00 AM

Medical Packaging Validation Strategies, Planning for Success

online event, Fremont, CA, USA

Overview:  Compliance to ISO 11607, Parts 1 and 2 require that Packaging Sterile Barrier Systems and Packaging Processes be validated. Validation planning is key to success. Inadequate planning will result in delayed time to market and ultimately financially negative impacts. Learn the differences of various distribution simulation industry standards and reasons why one methodology and testing approach may be indicated over another. You will have the opportunity to question the presenter who is a subject matter expert on packaging validations and medical package testing.  Areas Covered...

Medical Packaging Validation Strategies
regulatory compliance
Compliance regulatory training
Online Compliance training
Compliance4all created an event

WEBINAR

APR

09

10:00 AM

cGMPs in the Quality Control Laboratory

Online event, Fremont, CA, USA

Overview:  Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations. By careful review and analysis of the regulations, inspectional guidance, 483 observations and Warning Letter, internal audit observations and deviations, along with a review of laboratory practice and procedures, a laboratory can proactively identify areas for improvement. The...

Quality Control Laboratory
cGMP compliance
Compliance training