Skip to main content

Batch Production Record and Device History Record Review and Quality Assessment to ensure compliance with DMF and DMR specifications

Compliance Key INC - Medical Device Training

                                               Jerry Dalfors
Jerry Dalfors is Keynote Speaker at Compliance key Inc.He has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages.

  Webinar Id:  LSHCJB002
 12:30pm PT | 03:30pm ET 
 01/23/2018
 Duration: 60 mins
Overview
Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution
BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Production and laboratory control records for earlier, non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).
All incidents or deviations, investigation, and OOS, OOT, OOL reports should be reviewed to ensure there is no product quality impact by providing technically written sound scientific rationale for the assessment and conclusion as part of the batch record review before the batch is released.
Why should you attend this webinar?
A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation of the production processes for both injectables, devices and solid dosages.

Quality Systems require both Operations and Quality Departments to be unified with the overall intent of minimizing patient risk by documenting the process in a fashion that is technically accurate and easy to demonstrate that we are thinking and operating with the same objectives as the regulatory agencies are required to enforce.
Areas Covered in the Session:
  • Generation of BPRs, DHRs and SOPs to provide technically written instruction sets to eliminate operator errors. Training is NOT the primary means of generating and error free operation.
  • Production and In-Process Controls
  • Inspection, Packaging and Identification Labeling of Finished Products and Intermediates
  • Responsibilities for Production Activities
  • Data selection and entry into the statistical tracking from the BPR and DHR
  • Incident / Deviation Tracking along with Customer Complaints and CAPA changes
  • Annual Reports
Who can Benefit:
Quality and Documentation Personnel within the industry
Pharmaceutical, Medical Device and Solid Dosage as well as FDA, ISO, PDA, ISPE
Quality, Operations , Development Quality and Documentation Personnel within the industry. 

Visit:https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=972&speakerid=35
Compliance Key INC
717-208-8666

Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

Essentials of Affirmative Action and OFCCP Compliance

Compliance Key INC  -  Human Resource Training Online                                                                  Janette Levey Frisch Janette Levey Frisch is Keynote Speaker at Compliance key Inc. She is founder of  The EmpLAWyerologist Firm, has over 20 years of legal experience, more than 10 of which she has spent in Employment Law. It was during her tenure as sole in-house counsel for a mid-size staffing company headquartered in Central New Jersey, with operations all over the continental US, that she truly developed her passion for Employment Law.   Webinar Id:   CICJE001  10.00 AM PT | 01.00 PM ET   01/09/2018  Duration: 90 mins  Overview If you are a federal contractor, having a firm grasp on the essentials ...
Post a Comment
Read more

Understanding Design Controls

Compliance Key INC  -  Medical Device Training Overview Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation, however, the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Qua...
1 comment
Read more

Building a Compliance Program

Compliance Key INC  -  Compliance Training Webinar                                   Lisa M. Marsden Lisa M. Marsden, IACCP, is Keynote speaker at Compliance Key, Inc. She is the president and founder of Coulter Strategic Services. Coulter Strategic Services provides financial advisors and consulting firms with compliance and project management services. Prior to that, Ms. Marsden was the chief operating officer/chief compliance officer of Financial Trust Asset Management, Boca Raton, Florida.  Webinar Id:  CICLB005  10:30 AM PT | 01:00 PM ET  05/15/2018  Duration 60 mins  Overview Whether you are creating a new compliance program as a new CCO or a new firm or if you are updating an existing program this webinar will guide you through the process. Why should you attend this webinar? Rule 17j-1. Effective Date: A...
Post a Comment
Read more