1000+ Sessions conducted on USFDA,EMA and APAC

Good Documentation Guideline (Chapter <1029> USP)

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Friday, 27th April, 2018 01:00 PM EDT 10:00 AM PDT

Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system

This training session will cover the US Pharmacopeia General Chapter <1029> and all aspects of GDP including practices for writing and correcting documentation.

This 60-min webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Why should you attend

If you are involved in any product manufacturing, knowing GDP regulations is a must for you. It prevents a lot of errors and minimizes the chance of being spotted by the regulatory bodies in their audits.

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

Learning Highlights:

  • History of the chapter as to how and why it was created
  • Purpose of development of this chapter
  • Principles of Good Documentation
  • Data collection & recording
  • Different types of GMP Documents
  • Laboratory records
  • Equipment-related documentation
  • Deviations and investigations
  • Batch records
  • Certificate of Analysis (C of A)*
  • Standard Operating Procedure (SOP)*
  • Protocols & reports*
  • Analytical procedures*
  • Training documentation

FDA - Investigating OOS results

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Friday, 4th May, 2018 01:00 PM EDT 10:00 AM PDT

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Why should you attend

The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters.

Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.

The presentation will cover the following areas:

  • FDA requirements for handling OOS/ OOT results
  • Phase I- Laboratory Phase of Investigations
  • Phase II a Full Scale Investigation
  • Concluding an Investigation
  • Out-of Trend investigations
  • Common pitfalls during OOS Investigations
  • Review of recent OOS related citations in Warning Letters

21 CFR Part 11 Conformance for Medical Devices

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Thursday, 17th May, 2018 01:00 PM EST 10:00 AM PST

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.

The presentation will cover the following areas:

  • Patient Safety
  • How to Prevent Electronic Records
  • How 21 CFR part 11 considers both data security and patient safety.
  • The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained.

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